NCT01598090

Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Treatment With Peginterferon Alfa-2a and Ribavirin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 881 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
BIOLOGICAL	Peginterferon Lambda-1a	Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response
BIOLOGICAL	Peginterferon Alfa-2a	Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response
DRUG	Ribavirin	Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response
DRUG	Telaprevir	Tablets, Oral, 750 mg, three times a day, 12 weeks only

Timeline

• Start date: 2012-06-14
• Primary completion: 2015-02-04
• Completion: 2015-05-15
• First posted: 2012-05-15
• Last updated: 2019-07-31
• Results posted: 2019-05-21

Locations

104 sites across 15 countries: United States, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Poland, Russia, Spain, Switzerland, United Kingdom