GS-7977 With Ribavirin for Hepatitis C (SPARE)

Completed · Phase 1/Phase 2

Conditions studied: Hepatitis C

In brief

Background: \- GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by blocking the hepatitis C virus from dividing in the body. This medication has been used along with other medications commonly used to treat hepatitis C, such as interferon and ribavirin. When used with interferon and ribavirin, GS-7977 seems to be very effective in eliminating the hepatitis C virus from the body. However, interferon can have serious side effects, so researchers want to see if GS-7977 can work by itself or with only ribavirin. Objectives: \- To test the safety and effectiveness of GS-7977 alone or given with ribavirin for hepatitis C infection. Eligibility: \- Individuals at least 18 years of age who have hepatitis C with liver disease, and have never received drugs for it. Design: * This study will require multiple clinic visits over 18 months. A liver biopsy will be required before the start of the study if participants have not had one within the past 3 years. * Participants will be screened with a medical history and physical exam. * Participants will have either GS-7977 alone or GS-7977 with ribavirin. GS-7977 is taken by mouth once a day. Ribavirin is taken by mouth in the morning and evening. * Participants will have study visits on Days 1, 3, 5, 7, 10, and 14. These visits will involve regular blood tests and symptom monitoring. * After the second week, participants will have study visits during Weeks 3, 4, 6, 8, 12, 16, and 20. Blood and urine tests will be given to study virus levels in the body, and symptoms will be discussed. * Participants will stop receiving the study drugs at Week 24. * Followup clinic visits with blood tests will take place in Weeks 28, 36, 48, 52, 60, and 72. Another liver biopsy will be performed at 48 weeks. * Some participants may also be part of a smaller study. This study involves frequent blood draws to study drug and virus levels in the blood. The study will require a 36-hour hospital inpatient visit.

Key facts

Study ID

NCT01441180

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Starts

2011-09-01

Expected to finish

2014-07-01

Last updated by the study team

2014-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
• History of any other clinically significant chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson s disease, greater than or equal to 1-antitrypsin deficiency, alcoholic liver disease, > Grade 1 Stage 1 non-alcoholic steatohepatitis and toxin exposures).
• Treatment with unlicensed herbal/natural remedies suggested to be taken for hepatitis treatment such as Milk thistle or Cats Claw within 28 days of Day 0.
• Participants with a history of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease.
• Screening or baseline ECG with clinically significant ECG findings.
• A personal history of or first degree relative with a history of Torsade de pointes.
• Any substance detected during the screening process that, in the opinion of the investigator, is thought to affect protocol compliance or drug metabolism and disposition.
• Abnormal hematological and biochemical parameters, including:
• Neutrophil count < 1000 cells/mm(3)
• Hemoglobin < 11 g/dL in women and < 12 g/dL in men
• Platelet count less than or equal to 75,000 cells/mm(3)
• Estimated GFR, calculated by the CKD-EPI equation, < 50 mL/min/ per 1.73 m(2)
• ALT or AST greater than or equal to 10 times ULN
• Serum lipase greater than or equal to 1.5 times ULN (at Screening or during the Screening period)
• Total bilirubin greater than or equal to 2.0 times ULN (except in subjects with Gilbert s syndrome)
• Albumin less than or equal to 3.0 g/dL
• History of major organ transplantation with an existing functional graft.
• History of uncontrolled thyroid disease or abnormal TSH levels as defined < 0.8 times LLN or > 1.2 times ULN at Screening.
• Fasting blood glucose greater than or equal to 300 mg/dl or HbA1C greater than 9.
• Donation or loss of more than 400 mL blood within 8 weeks prior to first dose administration.
• History of clinically significant drug allergy to nucleoside/nucleotide analogs.
• History or current evidence of psychiatric illness, immunologic disorder, pulmonary, cardiac disease, seizure disorder, cancer or history of malignancy that in the opinion of the investigator makes the patient unsuitable for the study. Chronic medical conditions, especially if treated with medications (such as hypertension), must be stable at the time of screening. No new therapies should be started prior to the study that may confound the assessment of study drug safety.
• History of having received any systemic antineoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids > 10 mg/day for more than 6 weeks, and radiation) within 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
• Participation in a clinical study in which an investigational drug, biologic, or device was received within 12 weeks prior to first dose administration.
• Pregnant/Breastfeeding women or men whose partners are currently pregnant.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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