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Study Title: Boceprevir in Subjects with Previously Untreated Chronic HCV Genotype 1
Category: Gastroenterology
Currently accepting participants?
Not at this time.
Principal Investigator: Kris Kowdley
Study Coordinator: Cheryl Saunders
Phone: 206-341-1786
Email: cheryl.saunders@vmmc.org
What is the Boceprevir in Subjects with Previously Untreated Chronic HCV Genotype 1 study?
This study aims to compare the standard treatment for chronic hepatitis C infection (PegIntron + Ribavirin) to the standard care plus boceprevir (a new protease inhibitor used to prevent viral replication). It is also designed to examine whether a shorter treatment period with boceprevir is effective in patients with undetectable virus load after 8 weeks of treatment.
Patients will undergo 4 weeks of treatment with PegIntron + Ribivirin and will then be given either boceprevir or placebo for an additional 44 weeks.
Who can participate?
Men and Women over the age of 18 with a documented diagnosis of chronic hepatitis C genotype 1 who have not received any treatment for their disease.
What do I have to do as a study participant?
Study participants will need to be available to come to the VM clinic for study visits every 2 weeks for the first 3 months and once a month for remainder of the 18 month study. Participants will also need to be willing and able to consistently take study medication 3 times each day and must be comfortable with frequent blood draws.
Study Summary:
This study aims to compare the standard treatment for chronic hepatitis C infection (PegIntron + Ribavirin) to the standard care plus boceprevir (a new protease inhibitor used to prevent viral replication). It is also designed to examine whether a shorter treatment period with boceprevir is effective in patients with undetectable virus load after 8 weeks of treatment.
Patients will undergo 4 weeks of treatment with PegIntron + Ribivirin and will then be given either boceprevir or placebo for an additional 44 weeks.
Detailed Study Description:
(No information)
Study Design: Interventional, Blinded
Phase of Study: Phase III
Study Type: Interventional
Condition or Study Focus: Hepatitis C
Intervention Type: Drug
Intervention Name: Boceprevir
Gender: Male and Female
Age group: Interventional
Sponsor: Schering-Plough Research Institute
Other studies in this category include:
Studies currently accepting study participants:
- A Randomized Phase II/III of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
- A Study of INT-747 Monotherapy in Patients with Primary Biliary Cirrhosis
- Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction (EPISOD)
- Liver Disease Registry and Tissue Repository
- Nonalcoholic Fatty Liver Disease (NAFLD) Database 2.0
Studies currently not accepting study participants:
- 5-arm, parallel-group study of the effects on viral kinetics, safety and pharmacokinetics of different dosing regimens of Debio 025 in combination with peginterferon alpha-2a and ribavirin in chronic HCV genotype 1 patients who non-responders to standard
- A Phase 2b, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of GS-9450 in Adults with Chronic Hepatitis C Virus Infection
- A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease with AT-1001
- A study of INT-747 (6-ECDCA) in combination with ursodeoxycholic acid (URSO ®, UDCA) in patients with primary biliary cirrhosis
- Abatacept in Treatment of Patient with Active Crohns Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy
- Abatacept in Treatment of Patient with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy
- Boceprevir in Subjects with Previously Untreated Chronic HCV Genotype 1
- Randomized, placebo-controlled, multi-center study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy
- RG1068 (Synthetic Human Secretin) – Enhanced MRCP in the Evaluation of Subjects with a History of Acute or Acute Recurrent Pancreatitis