A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

Hepatitis C, Chronic Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703118
• Other study ID #: CR014842
• Secondary ID: VX-950-TIDP24-C2
• Status: Completed
• Phase: Phase 3
• First received: June 19, 2008
• Last updated: December 5, 2013
• Start date: October 2008
• Est. completion date: July 2010

Study information

• Verified date: December 2013
• Source: Tibotec BVBA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGreat Britain: Medicines and Healthcare Products Regulatory AgencyUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

Description:

This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in patients with chronic Hepatitis C Virus (HCV), genotype 1, infection who failed prior treatment with standard treatment. Standard treatment is defined as treatment with Peg-INF and RBV. The trial is designed to compare the efficacy, safety, and tolerability of 2 regimens of telaprevir (with and without delayed start) combined with standard treatment versus standard treatment alone. The trial will consist of a screening period of approximately 4 weeks, a 48-week treatment period, and a 24-week follow-up period. Patients will be eligible to enroll in the trial if they (1) had an undetectable HCV Ribonucleic Acid (RNA) level at the end of a prior course of standard treatment but did not achieve a response (viral relapsers), or (2) never had an undetectable HCV RNA level during or at the end of a prior course of standard treatment (non-responders). Approximately 650 patients (350 prior relapsers and 300 prior non-responders) will be randomized in a 2:2:1 ratio to one of 3 treatment groups: Treatment group A will receive telaprevir with standard treatment for 12 weeks; followed by placebo with standard treatment for 4 weeks; followed by standard treatment for 32 weeks. Treatment group B will receive placebo with standard treatment for 4 weeks; followed by telaprevir with standard treatment for 12 weeks; followed by standard treatment for 32 weeks. Treatment group C will receive placebo with standard treatment for 16 weeks; followed by standard treatment for 32 weeks. In both telaprevir regimens (A and B), patients will receive 12 weeks of 750 mg of telaprevir every 8 hours along with 48 weeks of standard treatment. Telaprevir or placebo will be given by mouth at a dose of 750 mg every 8 hours for 16 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV will be given by mouth at a dose of either 1000 or 1200 mg (depending on your body weight) two times per day for 48 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 663
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >= 1000 IU/mL

• Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)

• Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Exclusion Criteria:

• Patient is a previous non-responder that is classified as a viral breakthrough case

• Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype

• Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype

• Evidence of decompensated liver disease

• Patient has condition that requires use of systemic corticosteroids

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Telaprevir
Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.
• Peg-IFN-alfa-2a
Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.
• Ribavirin
Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.
• Placebo
Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tibotec BVBA	Tibotec Pharmaceutical Limited

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  France,  Germany,  Israel,  Netherlands,  Poland,  Puerto Rico,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned	SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.	Week 72	No
Secondary	Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4	RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.	Week 4	No
Secondary	Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)		Week 48	No
Secondary	Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned	SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).	Week 60	No
Secondary	Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8	Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels >100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.	Week 4, Week 6, or Week 8	No
Secondary	Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)	Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).	Up to Week 72	No
Secondary	Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4		Baseline (Day 1) to Week 4	No
Secondary	Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12	Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.	Week 4 and Week 12	No