Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics

Completed · Phase 4

Conditions studied: Hepatitis C, Cirrhosis

In brief

This is a randomized, open label, single center safety and efficacy study. At least 40 cirrhotic subjects with HCV genotype 3 will receive standard of care treatment of sofosbuvir and ribavirin (SOF/RBV) as well as 60 mg daily of Daclatasvir (investigational product). Subjects will be randomized in a 1:1 to receive either: * Group A: 16 weeks of DCV/SOF/RBV * Group B: 24 weeks of DCV/SOF/RBV Subjects will return to the study center at various time points throughout the 16 or 24 weeks of treatment in addition to 12 weeks post taking last dose of study drug to monitor safety and efficacy. These visits will be according to standard of care.

Key facts

Study ID

NCT02304159

Run by

Tarek I. Hassanein, M.D., FACP, FAG, AGAF

People needed

39

Starts

2015-01-01

Expected to finish

2017-08-01

Last updated by the study team

2019-04-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed, written, informed consent must be available from the subject before any study-specific procedures are performed;
• Male or female 18-75 years of age;
• All of the following at least 6 months prior to screening visit:
• Documented HCV infection based on history of a positive serum anti-HCV antibody test and/or detectable levels of HCV RNA >= 10,000 IU/mL, and
• Documented HCV genotype 3.
• Subjects with evidence of cirrhosis defined by either a liver biopsy <= 3 years from screening demonstrating a Metavir Fibrosis Score of F4 (or equivalent); OR Fibroscan® <= 1 year from screening > 12.5 kPa. If a subject is evaluated by more than one testing method, then the liver biopsy results take precedence;
• Women of childbearing potential (WOCBP) must:
• have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
• WOCBP must agree to follow instructions for method(s) of contraception for 7 months post-treatment completion.
• Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the following duration for 7 months post-treatment completion.
• Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% per year when used consistently and correctly.
• At minimum the subject agrees to the use of two methods of contraception, with at least one method being highly effective as listed below:
• Highly Effective Methods of Contraception
• Male condoms with spermicide
• Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants, and intrauterine devices (IUDs) such as Mirena® by male subject's WOCBP partner. Female partners of male subjects participating in the study may use hormone-based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug. WOCBP cannot use hormonal contraception as one of the two methods of contraception because there are no data on the effectiveness of systemic hormonal contraceptives in women taking SOF. However, WOCBP can continue to use hormonal contraceptives, if necessary, in addition to 2 other non-hormonal methods of contraception
• Nonhormonal IUDs, such as ParaGard®
• Tubal Ligation
• Vasectomy
• Complete Abstinence - defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs. Subjects who choose complete abstinence are not required to use a second method of contraception, but female subjects must continue to have pregnancy tests. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.
• Less Effective Methods of Contraception
• Diaphragm with spermicide
• Cervical cap with spermicide
• Vaginal sponge
• Male condom without spermicide
• Progestin only pills

You may not qualify if…

• Subjects who lack capacity to consent for themselves;
• HCV Genotypes other than GT-3 infection; mixed genotype infections are not permitted;
• Liver histology consistent with any other co-existing cause of chronic liver disease (apart from fatty liver and/or Chronic Hepatitis B Virus);
• Body Mass Index > 40 at the Screening visit;
• Any of the following within one month of screening:
• Uncontrolled diabetes;
• Unstable or uncontrolled thyroid disease (subjects requiring medication to control their thyroid disease are eligible if all other inclusion/exclusion criteria are met).
• Any of the following within 6 months of screening visit, any of the following:
• Decompensated liver disease, esophageal variceal bleeding, or a hepatic mass lesion suspicious for hepatocellular carcinoma (HCC);
• Subjects who have been treated for HCV infection;
• History of unstable or deteriorating cardiovascular or cerebrovascular disease;
• Alcohol and/or drug.
• QTcF ≥ 500 ms at the baseline visit.
• Any of the following laboratory abnormalities within 8 weeks of the baseline visit:
• Hemoglobin <8 g/dL;
• Absolute neutrophil count <0.50 x 103 cells/μL;
• Platelet count <25 x 103 cells/μL;
• Total bilirubin >=3 mg/dL or >=34 mol/L (with the exception of subjects with Gilbert's syndrome);
• Albumin <2.5g/dL;
• Creatinine Clearance (CrCl) <=50 mL/min (as estimated by Cockcroft and Gault).
• Serum ALT >=10 × ULN;
• Alpha-fetoprotein >200ng/mL.
• Prior exposure to NS5A inhibitors is prohibited but other classes and pegIFN/RBV are acceptable for treatment-experienced subjects;
• Use of any prohibited or restricted treatment at least is five half-lives or 14 days (whichever is longer) of the first dose of study drug (refer to section 4.5);
• History of cancer within 1 year of the screening visit with the exception of localized basal or squamous cell carcinoma;

Where it is running

• Southern California Research Center — Coronado, California, United States

Full record on ClinicalTrials.gov

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