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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR RIBAVARIN

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Clinical Trials for Ribavarin

Trial ID Title Status Sponsor Phase Summary
NCT00502970 Short Course of Interferon Treatment in Patients With HCV Infection Completed Getz Pharma Phase 4 To determine if a shorter course of interferon and ribavirin therapy will be sufficient in carefully selected patients with chronic hepatitis C virus genotype 3 infection, as compared to the standard length of treatment of 6 months.
NCT00502970 Short Course of Interferon Treatment in Patients With HCV Infection Completed Aga Khan University Phase 4 To determine if a shorter course of interferon and ribavirin therapy will be sufficient in carefully selected patients with chronic hepatitis C virus genotype 3 infection, as compared to the standard length of treatment of 6 months.
NCT00703872 HDV-Interferon in the Treatment of Chronic Hepatitis C Nonresponders and Naive Hepatitis C Patients Unknown status Hepasome Pharmaceuticals Phase 2 A Phase II, Open Label, Multi-Center, Proof-Of-Concept Study determing whether treatment with HDV-Interferon (HDV-IFN), by oral or subcutaneous (injection) routes, and ribavirin results in similar efficacy [Rapid Virologic Response (RVR)] and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin (historical control) in patients with chronic hepatitis C (treatment naïve by oral route and non-responders by SC route respectively).
NCT01458080 WEUSKOP5410: Observational Study in ENABLE Clinical Trials Completed GlaxoSmithKline N/A Hepatitis C Virus (HCV) is a leading cause of chronic liver disease (CLD) worldwide. Current mainstay of treatment is combination therapy with pegylated interferon and ribavarin. Thrombocytopenia as a treatment related adverse event or a complication of chronic liver disease often necessitates dose reduction and discontinuation in these patients. Revolade®/Promacta® (eltrombopag) is an oral second generation thrombopoietic growth factor in development for the treatment thrombocytopenia associated with various conditions, including secondary thrombocytopenia related to CLD and hepatitis C. In 2009 a phase III trial for CLD patients undergoing an elective invasive procedure (ELEVATE) was terminated early due to an imbalance of thromboembolic events (TEE) between the placebo and the eltrombopag arm. Currently, two global interventional Phase III trials (ENABLE 1 and ENABLE 2) are being conducted in approximately 1500 patients to evaluate the efficacy of eltrombopag in enabling HCV patients to achieve sustained viral response. Due to the similarities between the patient groups in ELEVATE and ENABLE, there is a concern that invasive procedures may influence the risk of TEE in the ENABLE population. This observational, non-interventional, retrospective, multicentre, nested case-control study will collect data from chart abstraction and medical record review to augment data from the ENABLE case report forms particularly with regards to invasive procedures. The study population includes cases and controls drawn from the ~1500 participants of the ENABLE trials. All eligible cases of TEE will be included in the study as cases. All other patients who participated in the ENABLE trials and did not experience a TEE, will be eligible to be selected as controls. Case report forms will be developed to enable standardized data capture. The Sponsor has contracted with the Clinical Research Organization, Outcome Sciences Inc to manage the study. ENABLE investigators will work with Outcome staff to obtain relevant information from the treating physician (e.g. surgeon) and the facility where the invasive procedure was performed (pre-operative tests, peri-operative course, diagnostic testing for TEE). Single point abstraction will be performed to obtain data from the medical record and from any additional data resources obtained by the investigator (e.g., operative note, anesthesia record). Analyses will be conducted using logistic regression models to estimate the risks. The primary objective of the study is to evaluate if there is an increased risk for TEE among patients who had an invasive procedure while exposed to eltrombopag (during the ENABLE trials).
NCT01563328 A Study to Evaluate the Effect of Boceprevir and Telaprevir on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697). Completed GlaxoSmithKline Phase 1 Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of human immunodeficiency virus (HIV) infection. Co-infection with Hepatitis C (HCV) is common in HIV-infected subjects therefore it is expected that DTG will be coadministered with treatments for HCV. Boceprevir (BCV) and Telaprevir (TVR) are protease inhibitors for the treatment of HCV that were recently approved by the Food and Drug Administration/European Medicines Agency (FDA/EMA) and have rapidly been adopted to "standard of care" in combination with pegylated interferon and ribavarin. This is a single-center, open-label, two-cohort, two-period, one-way, study in healthy adult subjects. A total of approximately 32 subjects will be enrolled, in order to obtain 24 evaluable subjects (12 per cohort). In the first treatment period, all subjects will receive DTG 50 mg once daily for 5 days (treatment A). In period 2, subjects will receive DTG 50 mg once daily plus either BCV 800 mg q8h (treatment B) for 10 days or TVR 750 mg q8h (treatment C) for 10 days. There will be no washout between treatments. Safety evaluations and serial PK samples will be collected during each treatment period. Subjects will have a screening visit within 30 days prior to the first dose of study drug, two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. This study will be conducted at one center in the US, with healthy adult male and female subjects.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ribavarin

Condition Name

Condition Name for Ribavarin
Intervention Trials
Hepatitis C 4
Infection, Human Immunodeficiency Virus 1
Hepatitis C Virus Infection 1
Chronic Hepatitis C 1
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Condition MeSH

Condition MeSH for Ribavarin
Intervention Trials
Hepatitis C 6
Hepatitis 5
Hepatitis A 2
Thalassemia 1
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Clinical Trial Locations for Ribavarin

Trials by Country

Trials by Country for Ribavarin
Location Trials
United States 1
India 1
Pakistan 1
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Trials by US State

Trials by US State for Ribavarin
Location Trials
Texas 1
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Clinical Trial Progress for Ribavarin

Clinical Trial Phase

Clinical Trial Phase for Ribavarin
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Ribavarin
Clinical Trial Phase Trials
Completed 3
Not yet recruiting 2
Unknown status 1
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Clinical Trial Sponsors for Ribavarin

Sponsor Name

Sponsor Name for Ribavarin
Sponsor Trials
GlaxoSmithKline 2
Gilead Sciences 2
ViiV Healthcare 1
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Sponsor Type

Sponsor Type for Ribavarin
Sponsor Trials
Industry 9
Other 2
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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Daiichi Sankyo
Federal Trade Commission
Merck
Johnson and Johnson
Teva
UBS
Medtronic
Boehringer Ingelheim

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