Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00410202
Registration number
NCT00410202
Ethics application status
Date submitted
11/12/2006
Date registered
12/12/2006
Date last updated
21/11/2013
Titles & IDs
Public title
Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus
Query!
Scientific title
A Comparative Study of Entecavir vs. Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-resistant Chronic Hepatitis B Subjects: The DEFINE Study
Query!
Secondary ID [1]
0
0
AI463-111
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
DEFINE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Entecavir
Treatment: Drugs - Tenofovir
Treatment: Drugs - Adefovir
Treatment: Drugs - Lamivudine
Active comparator: Entecavir - With the option of adding tenofovir at week 48. (This does not apply to Korea)
Active comparator: Adefovir + Lamivudine -
Active comparator: Entecavir + Adefovir -
Treatment: Drugs: Entecavir
Tablets, Oral, 1mg, once daily, 100 weeks
Treatment: Drugs: Tenofovir
Tablets, Oral, 300 mg, once daily
Treatment: Drugs: Adefovir
Tablets, Oral, 10mg, once daily, 100 weeks
Treatment: Drugs: Lamivudine
Tablets, Oral, 100mg, once daily, 100 weeks
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48
Query!
Assessment method [1]
0
0
HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. HBV DNA less than (\<)50 International units per milliliter (IU/mL) = approximately 300 copies/mL. Percentage of participants calculated n/N; n= number of participants with HBV DNA \<50 IU/mL; N = number of participants analyzed.
Query!
Timepoint [1]
0
0
Week 48
Query!
Secondary outcome [1]
0
0
Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96
Query!
Assessment method [1]
0
0
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. HBV DNA \< 50 IU/mL = approximately 300 copies/mL. Percentage n/N: n= number of participants with HBV DNA \<50 IU/mL; N = number of participants analyzed.
Query!
Timepoint [1]
0
0
Week 96
Query!
Secondary outcome [2]
0
0
Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48
Query!
Assessment method [2]
0
0
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed.
Query!
Timepoint [2]
0
0
Week 48
Query!
Secondary outcome [3]
0
0
Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96
Query!
Assessment method [3]
0
0
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed.
Query!
Timepoint [3]
0
0
Week 96
Query!
Secondary outcome [4]
0
0
Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48
Query!
Assessment method [4]
0
0
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.
Query!
Timepoint [4]
0
0
Week 48
Query!
Secondary outcome [5]
0
0
Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96
Query!
Assessment method [5]
0
0
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest amount or concentration of analyte in a sample, which can be reliably detected, but not necessarily quantified.
Query!
Timepoint [5]
0
0
Week 96
Query!
Secondary outcome [6]
0
0
Percentage of Participants With HBV DNA by PCR Category at Week 48
Query!
Assessment method [6]
0
0
HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay.
Query!
Timepoint [6]
0
0
Week 48
Query!
Secondary outcome [7]
0
0
Percentage of Participants With HBV DNA by PCR Category at Week 96
Query!
Assessment method [7]
0
0
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay.
Query!
Timepoint [7]
0
0
Week 96
Query!
Secondary outcome [8]
0
0
Change in Mean log10 From Baseline in HBV DNA at Week 48
Query!
Assessment method [8]
0
0
HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load, negative values means reduction.
Query!
Timepoint [8]
0
0
Baseline, Week 48
Query!
Secondary outcome [9]
0
0
Change in Mean log10 From Baseline in HBV DNA at Week 96
Query!
Assessment method [9]
0
0
HBV DNA was analyzed by PCR, using the Roche COBAS® TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load.
Query!
Timepoint [9]
0
0
Baseline, Week 96
Query!
Secondary outcome [10]
0
0
Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 48
Query!
Assessment method [10]
0
0
ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 or 48 U/L.
Query!
Timepoint [10]
0
0
Week 48
Query!
Secondary outcome [11]
0
0
Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 96
Query!
Assessment method [11]
0
0
ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.
Query!
Timepoint [11]
0
0
Baseline, Week 96
Query!
Secondary outcome [12]
0
0
Percentage of Participants With Confirmed HBeAg Loss at Week 48 (Treated HBeAg Positive Participants Only)
Query!
Assessment method [12]
0
0
HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week
Query!
Timepoint [12]
0
0
Week 48
Query!
Secondary outcome [13]
0
0
Percentage of Participants With Confirmed HBeAg Loss at Week 96 (Treated HBeAg Positive Participants Only)
Query!
Assessment method [13]
0
0
HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week
Query!
Timepoint [13]
0
0
Week 96
Query!
Secondary outcome [14]
0
0
Percentage of Participants With HBeAg Seroconversion at Week 48 (Treated HBeAg-positive Participants Only)
Query!
Assessment method [14]
0
0
HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).
Query!
Timepoint [14]
0
0
Week 48
Query!
Secondary outcome [15]
0
0
Percentage of Participants With HBeAg Seroconversion at Week 96 (Treated HBeAg-positive Participants Only)
Query!
Assessment method [15]
0
0
HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).
Query!
Timepoint [15]
0
0
Week 96
Query!
Secondary outcome [16]
0
0
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
Query!
Assessment method [16]
0
0
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.
Query!
Timepoint [16]
0
0
Week 48
Query!
Secondary outcome [17]
0
0
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 96
Query!
Assessment method [17]
0
0
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.
Query!
Timepoint [17]
0
0
Week 96
Query!
Secondary outcome [18]
0
0
Percentage of Participants With HBsAg Seroconversion at Week 48
Query!
Assessment method [18]
0
0
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.
Query!
Timepoint [18]
0
0
Week 48
Query!
Secondary outcome [19]
0
0
Percentage of Participants With HBsAg Seroconversion at Week 96
Query!
Assessment method [19]
0
0
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.
Query!
Timepoint [19]
0
0
Week 96
Query!
Secondary outcome [20]
0
0
Cumulative Probability of Emergent Genotypic Resistance at Year 1
Query!
Assessment method [20]
0
0
yr=year. Cumulative probability (CP): Ptotal=1-(1-Pyr1)\*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An "event" is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a = 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only).
Query!
Timepoint [20]
0
0
Year 1
Query!
Secondary outcome [21]
0
0
Cumulative Probability of Emergent Genotypic Resistance at Year 2
Query!
Assessment method [21]
0
0
Cumulative probability (CP): Ptotal=1-(1-Pyr1)\*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An "event" is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a = 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only).
Query!
Timepoint [21]
0
0
Year 2
Query!
Secondary outcome [22]
0
0
Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to Adverse Events or Laboratory Abnormalities During Treatment
Query!
Assessment method [22]
0
0
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade 1 = mild, Grade 2= moderate, Grade 3 = severe, Grade 4 = life threatening/disabling, Grade 5 = death.
Query!
Timepoint [22]
0
0
From start of study therapy through Week 100 + 5 days
Query!
Secondary outcome [23]
0
0
Number of Participants With Laboratory Abnormalities: Hematology
Query!
Assessment method [23]
0
0
Criteria for hematology abnormalities were: Hemoglobin: \<=11.0 g/dL; White Blood Cells: \<4000/mm\^3; Absolute Neutrophils (includes absolute bands): \<1500/mm\^3; Platelets: \<=99,000/mm\^3; International Normalized Ratio: = 1.5 and = 0.5 from baseline.
Query!
Timepoint [23]
0
0
From start of study through Week 100 + 5 days
Query!
Secondary outcome [24]
0
0
Number of Participants With Laboratory Abnormalities: Serum Chemistry
Query!
Assessment method [24]
0
0
ULN=upper limit of normal (Normal ranges are Central lab data and vary according to the site). ALT:\>1.25\*ULN, AST:\>1.25\*ULN, ALP:\>1.25\*ULN, Total Bilirubin:\>1.1\*ULN, Serum Lipase:\>1.10\*ULN, Creatinine:\>1.1\*ULN, Blood Urea Nitrogen:1.25\*ULN, Hyperglycemia:\>116 mg/dL, Hypoglycemia:\<64 mg/dL, Hyponatremia:\<132meq/L, Hypokalemia:\<3.4 meq/L, Albumin:=1g/dL decrease from baseline, \<3 g/dL; Hypernatremia:\>148 meq/L, Hyperkalemia:\>5.6 meq/L, Hypokalemia:\<3.4 meq/L, Hyperchloremia:\>113 meq/L, Hypochloremia:\<93 meq/L; ALT flare: on treatment (OT), \>2\*Baseline and \>10\*ULN; off treatment (OF), 2\*end of dosing value and \>10\*ULN
Query!
Timepoint [24]
0
0
On treatment : Day 1 through Week 100 + 5 days; Offtreatment = End of OT period through 24 weeks
Query!
Eligibility
Key inclusion criteria
* Evidence of lamivudine (LVD) resistance
* Subjects must have a history of previous LVD treatment at screening, and must have evidence of at least 1 LVD resistance substitution (valine, isoleucine, or serine) at reverse transcriptase codon 204 (M204V/I/S)
* Nucleoside- and nucleotide-naive, except for LVD, and had chronic hepatitis B (HBV) infection
* Compensated liver function and must have met ALL of the following criteria:International normalization ratio (INR) = 1.5; Serum albumin = 3 g/dL (= 30 g/L); Serum total bilirubin = 2.5 mg/dL (= 42.75 µmol/L)
* HBV DNA > 1.72 x 10*4* IU/mL (approximately 10*5* copies/mL)
* Documentation of hepatitis B e antigen (HBeAg) positive and hepatitis B e antibody (HBeAb) negative status at screening
* alanine aminotransferase (ALT) = 10 * upper limit of normal (ULN) at screening
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to 6 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized
* WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. Post menopausal is defined as:
* Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential
* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 72 hours prior to the start of investigational product
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Evidence of decompensated cirrhosis
* Coinfection with human immunodeficiency virus, hepatitis C virus , or hepatitis D virus
* Women who are pregnant or breastfeeding
* Sexually active fertile men not using effective birth control if their partners were WOCBP
* Laboratory values out of protocol-specified range
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/07/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
629
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Local Institution - Concord
Query!
Recruitment hospital [2]
0
0
Local Institution - Randwick
Query!
Recruitment postcode(s) [1]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [2]
0
0
2031 - Randwick
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Connecticut
Query!
Country [2]
0
0
Brazil
Query!
State/province [2]
0
0
Rio Grande Do Sul
Query!
Country [3]
0
0
Canada
Query!
State/province [3]
0
0
Alberta
Query!
Country [4]
0
0
Greece
Query!
State/province [4]
0
0
Athens
Query!
Country [5]
0
0
Hong Kong
Query!
State/province [5]
0
0
New Territories
Query!
Country [6]
0
0
Hong Kong
Query!
State/province [6]
0
0
Hong Kong
Query!
Country [7]
0
0
Hong Kong
Query!
State/province [7]
0
0
Tai Po
Query!
Country [8]
0
0
India
Query!
State/province [8]
0
0
Uttar Pradesh
Query!
Country [9]
0
0
India
Query!
State/province [9]
0
0
Ahmedabad
Query!
Country [10]
0
0
India
Query!
State/province [10]
0
0
Chandigarh
Query!
Country [11]
0
0
India
Query!
State/province [11]
0
0
Indore
Query!
Country [12]
0
0
India
Query!
State/province [12]
0
0
Ludhiana
Query!
Country [13]
0
0
India
Query!
State/province [13]
0
0
New Delhi
Query!
Country [14]
0
0
India
Query!
State/province [14]
0
0
Vellore
Query!
Country [15]
0
0
Indonesia
Query!
State/province [15]
0
0
Jakarta
Query!
Country [16]
0
0
Italy
Query!
State/province [16]
0
0
Antella, Firenze
Query!
Country [17]
0
0
Korea, Republic of
Query!
State/province [17]
0
0
Dongdaemun-Gu
Query!
Country [18]
0
0
Korea, Republic of
Query!
State/province [18]
0
0
Donggu
Query!
Country [19]
0
0
Korea, Republic of
Query!
State/province [19]
0
0
Gyeonggi-Do
Query!
Country [20]
0
0
Korea, Republic of
Query!
State/province [20]
0
0
Ilsanseo Gu
Query!
Country [21]
0
0
Korea, Republic of
Query!
State/province [21]
0
0
Jung-Gu
Query!
Country [22]
0
0
Korea, Republic of
Query!
State/province [22]
0
0
Nowon-Gu
Query!
Country [23]
0
0
Korea, Republic of
Query!
State/province [23]
0
0
Chuncheon-Si
Query!
Country [24]
0
0
Korea, Republic of
Query!
State/province [24]
0
0
Daegu
Query!
Country [25]
0
0
Korea, Republic of
Query!
State/province [25]
0
0
Gangneung
Query!
Country [26]
0
0
Korea, Republic of
Query!
State/province [26]
0
0
Incheon
Query!
Country [27]
0
0
Korea, Republic of
Query!
State/province [27]
0
0
Pusan
Query!
Country [28]
0
0
Korea, Republic of
Query!
State/province [28]
0
0
Seoul
Query!
Country [29]
0
0
Korea, Republic of
Query!
State/province [29]
0
0
Suwon
Query!
Country [30]
0
0
Korea, Republic of
Query!
State/province [30]
0
0
Yangsan-Si
Query!
Country [31]
0
0
Malaysia
Query!
State/province [31]
0
0
Sabah
Query!
Country [32]
0
0
Malaysia
Query!
State/province [32]
0
0
Kuala Lumpur
Query!
Country [33]
0
0
Philippines
Query!
State/province [33]
0
0
Cebu City
Query!
Country [34]
0
0
Philippines
Query!
State/province [34]
0
0
Manila
Query!
Country [35]
0
0
Poland
Query!
State/province [35]
0
0
Chorzow
Query!
Country [36]
0
0
Poland
Query!
State/province [36]
0
0
Kielce
Query!
Country [37]
0
0
Poland
Query!
State/province [37]
0
0
Lodzi
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Lublin
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Warszawa
Query!
Country [40]
0
0
Russian Federation
Query!
State/province [40]
0
0
Moscow
Query!
Country [41]
0
0
Russian Federation
Query!
State/province [41]
0
0
St. Petersburg
Query!
Country [42]
0
0
Singapore
Query!
State/province [42]
0
0
Singapore
Query!
Country [43]
0
0
Taiwan
Query!
State/province [43]
0
0
Kaohsiung
Query!
Country [44]
0
0
Taiwan
Query!
State/province [44]
0
0
Tainan R.O.C.
Query!
Country [45]
0
0
Taiwan
Query!
State/province [45]
0
0
Taipei
Query!
Country [46]
0
0
Taiwan
Query!
State/province [46]
0
0
Taoyuan
Query!
Country [47]
0
0
Thailand
Query!
State/province [47]
0
0
Bangkok
Query!
Country [48]
0
0
Thailand
Query!
State/province [48]
0
0
Chiang Mai
Query!
Country [49]
0
0
Turkey
Query!
State/province [49]
0
0
Bornova Izmir
Query!
Country [50]
0
0
Turkey
Query!
State/province [50]
0
0
Trabzon
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine
Query!
Trial website
https://clinicaltrials.gov/study/NCT00410202
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00410202
Download to PDF