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Last Updated: May 28, 2022

CLINICAL TRIALS PROFILE FOR REBETOL


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All Clinical Trials for Rebetol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00018031 ↗ Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 2001-06-01 This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b. This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher blood concentration and thus maintaining activity against the hepatitis C virus. HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is not available. The liver biopsy is done to determine the severity of liver disease. For this test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is injected into an arm vein, the skin in the area over the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray, electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening tests, candidates who appear eligible for the study will have a physical examination, medical history and repeat blood tests. Women who can become pregnant will have serial pregnancy tests throughout the study. Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth. In addition, patients will continue to take all other medications prescribed by their doctor. Clinic visits will be scheduled as follows: - Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV. - Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection. - Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients will return to the clinic for a routine test.
NCT00039871 ↗ PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370) Completed Merck Sharp & Dohme Corp. Phase 3 2002-05-01 The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).
NCT00081770 ↗ Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471) Completed Merck Sharp & Dohme Corp. Phase 3 2004-03-01 The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
NCT00087607 ↗ Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC). Completed Hoffmann-La Roche Phase 4 2004-01-01 This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
NCT00104052 ↗ Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1) Completed Merck Sharp & Dohme Corp. Phase 3 2005-02-01 The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in pediatric subjects with chronic hepatitis C.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rebetol

Condition Name

Condition Name for Rebetol
Intervention Trials
Hepatitis C, Chronic 47
Hepatitis C 29
Chronic Hepatitis C 19
Hepacivirus 6
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Condition MeSH

Condition MeSH for Rebetol
Intervention Trials
Hepatitis C 89
Hepatitis 84
Hepatitis C, Chronic 74
Hepatitis A 74
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Clinical Trial Locations for Rebetol

Trials by Country

Trials by Country for Rebetol
Location Trials
United States 59
Japan 8
Canada 4
Spain 4
Italy 4
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Trials by US State

Trials by US State for Rebetol
Location Trials
California 6
Texas 6
Virginia 5
New York 4
Florida 3
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Clinical Trial Progress for Rebetol

Clinical Trial Phase

Clinical Trial Phase for Rebetol
Clinical Trial Phase Trials
Phase 4 18
Phase 3 19
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Rebetol
Clinical Trial Phase Trials
Completed 69
Terminated 15
Withdrawn 6
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Clinical Trial Sponsors for Rebetol

Sponsor Name

Sponsor Name for Rebetol
Sponsor Trials
Merck Sharp & Dohme Corp. 55
Schering-Plough 6
TCM Biotech International Corp. 2
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Sponsor Type

Sponsor Type for Rebetol
Sponsor Trials
Industry 84
Other 54
NIH 2
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