Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C

NCT00372385 | Completed Phase 2 Results DMC

• 1 other identifier: VX05-950-104EU
• Study Type: interventional
• Target: 334
• Locations: 4 countries
• Sites: 4

Brief Summary

Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing

  The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

  24 weeks after the completion of study drug dosing (up to Week 72)

Secondary Outcomes (5)

• Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing

  12 weeks after the completion of study drug dosing (up to Week 60)

• Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing

  Completion of study drug dosing (up to Week 48)

• Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to Week 48

• Number of Subjects With Viral Relapse

  After last dose of study drug up to antiviral follow-up (up to Week 72)

• Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir

  Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85

Study Arms (4)

PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week

PLACEBO COMPARATOR

Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.

Drug: Ribavirin; Drug: Pegylated Interferon Alfa 2a; Drug: Placebo

Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week

EXPERIMENTAL

Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.

Drug: Ribavirin; Drug: Pegylated Interferon Alfa 2a; Drug: Telaprevir

Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week

EXPERIMENTAL

Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.

Drug: Ribavirin; Drug: Pegylated Interferon Alfa 2a; Drug: Telaprevir

Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week

EXPERIMENTAL

Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.

Drug: Pegylated Interferon Alfa 2a; Drug: Telaprevir

Interventions

Ribavirin DRUG

tablet

PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week; Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week; Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week

Pegylated Interferon Alfa 2a DRUG

Solution for injection

PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week; Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week; Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week; Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week

Placebo DRUG

tablet

PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week

Telaprevir DRUG

tablet

Also known as: VX-950

Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week; Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week; Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
• Have been infected with Hepatitis C virus for greater than (\>) 6 months
• Seronegative for hepatitis B surface antigen and human immunodeficiency virus 1 and 2
• Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
• Female subjects must have a negative pregnancy test at all visits before the first dose.

You may not qualify if:

• Received any approved or investigational drug or drug regimen for the treatment of hepatitis C.
• Any medical contraindications to Peg-IFN-alfa-2a or Ribavirin therapy
• Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis.
• Diagnosed or suspected hepatocellular carcinoma.
• Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before Study start.
• Alcohol/drug abuse or excessive use in the last 12 months.
• Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (4)

Call For Information

Call For Information, Austria

Location

Call For Information

Call For Information, France

Location

Call For Information

Call For Information, Germany

Location

Call for Information

Call For Information, United Kingdom

Location

Related Publications (1)

• Hezode C, Forestier N, Dusheiko G, Ferenci P, Pol S, Goeser T, Bronowicki JP, Bourliere M, Gharakhanian S, Bengtsson L, McNair L, George S, Kieffer T, Kwong A, Kauffman RS, Alam J, Pawlotsky JM, Zeuzem S; PROVE2 Study Team. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med. 2009 Apr 30;360(18):1839-50. doi: 10.1056/NEJMoa0807650.

  PMID: 19403903 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin; peginterferon alfa-2a; telaprevir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Jeff Chodakewitz, M.D.
• Organization: Vertex Pharmaceuticals Incorporated

Jeff_Chodakewitz@vrtx.com

617-341-6777

Study Officials

• Medical Monitor

  Vertex Pharmaceuticals Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2006
• First Posted: September 6, 2006
• Study Start: August 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 23, 2014
• Results First Posted: July 21, 2011

Record last verified: 2014-06

Locations

DE (1); FR (1); AU (1); GB (1)