Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01989208




Registration number
NCT01989208
Ethics application status
Date submitted
13/11/2013
Date registered
20/11/2013
Date last updated
5/05/2020

Titles & IDs
Public title
Assessing the Safety and Ability of SG1002 to Overcome Deficits in Hydrogen Sulfide in Heart Failure Patients
Scientific title
A Dose Escalation Study to Assess the Safety and Ability of SG1002 to Overcome Circulating Deficits in Hydrogen Sulfide Found in Heart Failure Patients
Secondary ID [1] 0 0
SG1002-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - SG1002
Other interventions - Placebo

Placebo comparator: Sugar capsule - One normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.

Experimental: SG1002 - 200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)


Other interventions: SG1002
200 mg capsules will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days.

Other interventions: Placebo
200 mg capsules containing placebo will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Adverse Events
Timepoint [1] 0 0
Following 7 days of treatment at each of three doses
Secondary outcome [1] 0 0
Assessing Changes in Peak Hydrogen Sulfide Levels in Heart Failure Subjects Following SG1002 Administration.
Timepoint [1] 0 0
24 hours

Eligibility
Key inclusion criteria
Inclusion Criteria (healthy volunteers):

* Healthy male volunteers aged between 18 and 45 years (inclusive);
* Body mass index between 19 and 30 kg/m^2 (inclusive);
* No clinically significant findings in the medical history and physical examination;
* No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant;
* Normal ECG, blood pressure and heart rate, unless the Investigator considers any abnormality to be not clinically significant (NCS);
* Willing to use contraception (single barrier methods); and
* Willing and able to provide written informed consent.
Minimum age
35 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria (healthy volunteers):

* Have received blood products within 1 month prior to Screening;
* Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of trial medical food;
* Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the trial medical food;
* Have a history of thyroidectomy or thyroid disease that required medication within the past 12 months;
* Have had serious angioedema episodes within the previous 3 years or requiring medication in the previous two years;
* Have a bleeding disorder diagnosed by a doctor (for example factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties during blood draws;
* Have a psychiatric condition that precludes compliance with the protocol, past or present psychoses, past or present bipolar disorder, or a disorder requiring lithium, within five years prior to enrolment;
* Has a history of suicide plan;
* Any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead ECG, or positive urine screen for drugs of abuse;
* Any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk;
* HIV, or hepatitis B or C positive;
* Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder;
* Have a history of or current tuberculosis, epilepsy, diabetes or glaucoma;
* Have clinical signs of active infection or a temperature more than 38.0°C at the time of screening. Study entry may be deferred at the discretion of the Principal Investigator;
* Have evidence of drug or alcohol abuse;
* Be unable to provide repeated blood samples without undue trauma or distress;
* Anticipate surgery within the trial period; or
* Inability to speak English (due to need to administer standardized English-language questionnaire).

Inclusion Criteria (heart failure subjects):

* Aged between 35 and 85 years (inclusive);
* Has symptomatic heart failure, with New York Heart Association (NYHA)classification of II or III;
* Ambulatory;
* Left ventricular ejection fraction less than 40%;
* Congestive heart failure has been stable for the previous 3 months (defined by no change in baseline therapy or symptoms of heart failure for the previous 3 months); and
* Willing and able to provide written informed consent.

Exclusion Criteria (heart failure subjects):

* Subject is pregnant or breastfeeding;
* If female, the subject is either post-menopausal or surgically sterilised or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from signing of the informed consent form though to the Final Visit/Early Termination Visit;
* Myocardial infarction, unstable angina, stroke, cerebrovascular accident, percutaneous coronary intervention, open heart surgery or transient ischemic attack (TIA) within 3 months prior to Screening;
* Current symptomatic hypotension (defined as systolic blood pressure (SBP) = 90 mmHg or diastolic blood pressure (DBP) = 40 mmHg);
* Poorly controlled hypertension (defined as SBP = 160 mmHg or DBP = 100 mmHg) despite therapy
* Subjects with NYHA grade IV heart failure;
* Subjects awaiting percutaneous coronary intervention or open heart surgery;
* Subjects with serious liver disease;
* Subjects with liver function test results three times the upper limit of normal.
* Any change in cardiovascular drug therapy within three months prior to randomization
* History of chronic obstructive pulmonary disease (diagnosed using GOLD criteria) or evidence of restrictive lung disease (defined as forced expiratory volume (FEV1) to forced vital capacity (FCV) ratio of > 80%);
* Poorly controlled diabetes (defined as HbA1c > 10.0 %);
* Has undergone Cardiac Resynchronisation Therapy (CRT) in the last 6 months and no planned CRT;
* Implantable cardioverter defibrillator (ICD) implant planned during the study;
* Hypersensitivity to sulfur or related compounds;
* Renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) < 30 mL/minute/1.73 m2 (Modification of Diet in Renal Disease Study MDRD) [2];
* Life expectancy less than 6 months;
* Active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the investigator, interfere with study treatment or participation. (Stable basal cell skin cancer and cancers being treated solely with hormonal therapy are allowed.)
* Inability to speak English (due to need to administer standardized English-language questionnaire); or
* Any other chronic illness that may, in the opinion of the Investigator, increase the risks associated with this trial.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment hospital [2] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sulfagenix Australia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MD, PhD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT01989208