Combination Therapy for Chronic Hepatitis C Infection

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

Background: \- GS-7977, GS-5885, GS-9669, and GS-9451 are new drugs for treating hepatitis C virus (HCV) infection. GS-7977 may help treat the infection when used with other treatments like interferon therapy. GS-5885, and GS-9669, and GS-9451 also lower the amount of HCV in the body. Researchers want to see whether GS-7977 can be combined with any of the other three drugs to treat HCV infection. Some participants will take GS-7977 and GS-5885. Others will take GS-7977, GS-5885 and GS-9669 or GS-7977, GS-5885 and GS-9451. Objectives: \- To see whether GS-7977 with GS-5885 alone or in combination with either GS-9669 or 9451 can be used to treat HCV infection. Eligibility: Individuals at least 18 years of age who have chronic HCV infection and have never been treated for it. Individuals at least 18 years of age who have chronic HCV infection and have not responded to interferon therapy. Individuals at least 18 years of age who have chronic HCV infection with advanced liver disease and have never been treated for HCV Design: Participants will be screened with a physical exam and medical history. Blood samples will be collected. A liver biopsy may also be performed. Some participants will take the two study drugs and some will take three study drugs. Those who take GS-7977 and GS-5885 will have one daily tablet named fixed dose combination or FDC. Those who take GS-7977 and CS-9669 will have three daily tablets taken once daily. Those who take GS-7977 and GS-5885 and GS-9451 will take 2 pills once a day. GS-7977 and GS-5885 will be combined in one pill and GS-9451 will be in another pill. Treatment will be monitored with frequent blood tests. These tests will check liver function and the level of HCV infection. Participants may have other blood tests as needed for treatment. Participants will have 4, 6 or 12 weeks of treatment depending on which study drugs are scheduled to take. After they complete their schedule, they will stop treatment with the study drugs. They may also have another liver biopsy. Participants will have regular follow-up visits over the next 48 weeks. They will have physical exams and provide blood samples....

Key facts

Study ID: NCT01805882
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 229
Starts: 2013-01-01
Expected to finish: 2015-08-01
Last updated by the study team: 2017-06-08

Who can join

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

You may not qualify if…

Current or prior history of any of the following:
Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
Gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug.
Poor venous access interfering with required study blood collection.
Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
Solid organ transplantation.
Significant pulmonary disease, significant cardiac disease or porphyria.
Unstable psychiatric disease (Subjects with psychiatric illness that is well-controlled on a stable treatment regimen or currently not requiring medication may be included).
Any malignancy or its treatment that in the opinion of the PI may cause ongoing interference with host immunity; subjects under evaluation for malignancy are not eligible.
Significant drug allergy (such as anaphylaxis or hepatotoxicity).
Substance abuse, which in the opinion of the investigator is likely to interfere with medication adherence or study compliance.
Lactose allergy, patients with lactose intolerance will be evaluated on a case-by-case basis.
Positive test results at screening for hepatitis B virus (HBV) surface antigen (HBsAg), HBV DNA (if medically indicated) or anti-HIV antibody (unless previously treated on 13-I-0159).
Prior exposure to any direct-acting antivirals for HCV infection, except for patients who were previously treated studies 11-I-0258, 13-I-1059 or this study enrolling in Group D.
History of clinically significant chronic liver disease due to other etiology (e.g., hemochromatosis, autoimmune hepatitis, Wilson s disease, alpha 1-antitrypsin deficiency, alcoholic liver disease, > moderate non-alcoholic steatohepatitis and toxin exposures).
Use of herbal/natural remedies for potential benefit to the liver within 21 Days of Day 0.
History of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease.
Screening or baseline ECG with clinically significant ECG findings, or a personal/first degree relative history of Torsade de pointes.
Abnormal hematological and biochemical parameters at screening, including:
Neutrophil count less than 750 cells per cubic millimeter.
Hemoglobin level < 9 g/dL. If Hgb < 11g/dL in women and < 12 g/dL in men other causes of anemia should be excluded as medically indicated.
Platelet count less than or equal to 50,000 cells per cubic millimeter.
Estimated glomerular filtration rate less than 50 milliliter/min/1.73m(2).
ALT or AST level greater than or equal to 10 times upper limit of normal (ULN).
Serum lipase level greater than or equal to 1.5 times upper limit of normal (ULN)at screening or during the screening period in a patient with symptoms consistent with pancreatitis.

Where it is running

Unity Health Care, Inc./DC General — Washington D.C., District of Columbia, United States
Family Medical and Conseling Services — Washington D.C., District of Columbia, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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