VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

NCT ID: NCT01054573

Last Updated: 2013-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-05-31

Brief Summary

The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

Detailed Description

This is an open-label (i.e all people involved know the identity of the intervention), single-arm, roll-over trial of telaprevir in combination with pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV). The purpose of the trial is to provide access to telaprevir for patients who were randomized to the control group in the VX-950-TiDP24-C216 trial (referred to as C216 trial hereafter) and who failed therapy for virologic reasons. The efficacy, safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV will be evaluated. In addition, amino acid changes from baseline in the HCV NS3 (i.e protein associated with the hepatitis C virus) protease domain will be evaluated. The trial will consist of a screening period of approximately 28 days, a 48-week treatment period, and a 24-week follow-up period. It is expected that approximately 120 patients could be eligible for enrollment. Since the C216 trial is blinded until all patients reach Week 72 (or have discontinued earlier), patients can only enter the current trial upon invitation. The investigator will receive an invitation sent by the unblinded independent virology monitor of the C216 trial for those patients of the C216 trial who were randomized to the control group and who failed therapy for virologic reasons. Next to this invitation, the patient will need to fulfill the inclusion and exclusion criteria of the current trial in order to be eligible to participate. The screening visit for the current trial can only occur after the patient completes all assessments in the C216 trial, including the Safety Follow-up Visit. Patients must not enter this trial later than 80 weeks after their first dose in the C216 trial. In the current trial, all patients will receive 12 weeks of telaprevir 750 mg every 8 hours (q8h) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly and 1,000 or 1,200 mg/day (weight based), respectively, followed by 36 weeks of Peg IFN alfa 2a and RBV at standard doses. Patients with hepatitis C virus RNA levels < 25 IU/mL undetectable at the end of treatment (Week 48 or having discontinued earlier) will be followed for 24 weeks after the last dose of study medication to assess sustained virologic response (SVR). Safety/tolerability assessments will be performed and adverse events (AEs), regardless of severity, will be collected continuously until the Safety Follow-up Visit, scheduled 4 weeks after the last dose of study medication. Thereafter, only serious adverse events (SAEs) will be reported. All patients will receive 12 weeks of telaprevir 750 mg q8h (orally) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly (injection) and 1,000 or 1,200 mg/day (weight-based) (orally), respectively, followed by 36 weeks of Peg IFN alfa-2a and RBV at standard doses.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telaprevir + Standard Treatment

Telaprevir 750 mg orally (by mouth) every 8h for 12 weeks plus standard treatment. Standard treatment is 180 mcg subcutaneous (under the skin) injection pegylated interferon (Peg-IFN) alfa-2a and 1000-1200 mg twice daily ribavirin (RBV) for 48 weeks.

Group Type: EXPERIMENTAL

Telaprevir

Intervention Type: DRUG

750 mg orally every 8 hours (q8h) for 12 weeks

pegylated interferon (Peg-IFN) alfa-2a

Intervention Type: DRUG

180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.

ribavirin (RBV)

Intervention Type: DRUG

1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.

Interventions

Telaprevir

750 mg orally every 8 hours (q8h) for 12 weeks

Intervention Type: DRUG

pegylated interferon (Peg-IFN) alfa-2a

180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.

Intervention Type: DRUG

ribavirin (RBV)

1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient from the control group of the C216 study who failed therapy for virologic reasons
• Patient must have completed all assessments in the C216 trial
• 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 received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial
• Patient has history of decompensated liver disease
• Patient has history of acute or chronic pancreatitis
• Patient has condition that requires use of systemic corticosteroids
• Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment
• Patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: collaborator

Janssen Infectious Diseases BVBA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Infectious Diseases BVBA Clinical Trial

Role: STUDY_DIRECTOR

Janssen Infectious Diseases BVBA

Locations

Coronado, California, United States

Los Angeles, California, United States

San Francisco, California, United States

Bradenton, Florida, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

Kansas City, Missouri, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Philadelphia, Pennsylvania, United States

Columbia, South Carolina, United States

Houston, Texas, United States

San Antonio, Texas, United States

Adelaide, , Australia

Clayton, , Australia

Darlinghurst, , Australia

Perth, , Australia

Brussels, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Distrito Barao Geraldo-Campina, , Brazil

Salvador, , Brazil

São Paulo, , Brazil

Montreal, Quebec, Canada

Clichy, , France

Créteil, , France

Lille, , France

Pessac, , France

Berlin, , Germany

Cologne, , Germany

Frankfurt, , Germany

Hamburg, , Germany

Hanover, , Germany

München, , Germany

Petah Tikva, , Israel

Safed, , Israel

Amsterdam, , Netherlands

Nijmegen, , Netherlands

Bialystok, , Poland

Czeladź, , Poland

Warsaw, , Poland

San Juan, , Puerto Rico

Barcelona, , Spain

Valencia, , Spain

Stockholm, , Sweden

Zurich, , Switzerland

London, , United Kingdom

Countries

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

References

Susser S, Flinders M, Reesink HW, Zeuzem S, Lawyer G, Ghys A, Van Eygen V, Witek J, De Meyer S, Sarrazin C. Evolution of hepatitis C virus quasispecies during repeated treatment with the NS3/4A protease inhibitor telaprevir. Antimicrob Agents Chemother. 2015 May;59(5):2746-55. doi: 10.1128/AAC.04911-14. Epub 2015 Feb 23.

Reference Type: DERIVED

PMID: 25712364 (View on PubMed)

Other Identifiers

VX-TiDP24-C219

Identifier Type: OTHER

Identifier Source: secondary_id

2009-012613-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR016678

Identifier Type: -

Identifier Source: org_study_id