A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

NCT00420784 | Completed Phase 2 Results DMC

• 1 other identifier: VX06-950-106
• Study Type: interventional
• Target: 465
• Locations: 5 countries
• Sites: 53

Brief Summary

The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.

Conditions

Hepatitis C

Keywords

Genotype 1

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 Completion of Study Drug Dosing

  Completion of study drug dosing (up to Week 48)

• Percentage of Subjects With Undetectable Plasma HCV RNA

  Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)

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

  Baseline up to 2 weeks after last dose of study drug (up to Week 50)

• Number of Subjects With Viral Relapse

  After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)

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

  Week 2, 4, 8, 12, 16, 24

Study Arms (4)

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

EXPERIMENTAL

Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet 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) tablet 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 24 weeks.

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

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

EXPERIMENTAL

Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 48 weeks.

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

Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week

EXPERIMENTAL

Single loading dose of telaprevir 1125 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 24 weeks.

Drug: Telaprevir; Drug: Pegylated Interferon Alfa 2a

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

PLACEBO COMPARATOR

Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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 48 weeks.

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

Interventions

Telaprevir DRUG

tablet

Also known as: VX-950

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

Ribavirin DRUG

tablet

Also known as: RBV

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

Pegylated Interferon Alfa 2a DRUG

Solution for injection

Also known as: Peg-IFN-alfa-2a

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

Matching Placebo DRUG

Tablet

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 18 and 70 years old
• Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (\>=) 10,000 international units per milliliter (IU/mL)
• Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
• Cannot also be infected with Human Immunodeficiency Virus or hepatitis B
• Must be judged to be in general good health and able to receive Pegasys® and Copegus®
• No drug or alcohol abuse in the last year
• Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
• If you are a woman, you cannot be in this study if you are pregnant or nursing

You may not qualify if:

• Participation in any clinical trial of a HCV protease inhibitor of any duration
• Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
• 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
• History of or current evidence of decompensated liver disease
• Participation in any clinical trial of an investigational drug 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 (53)

Birmingham Gastroenterology Associates

Birmingham, Alabama, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

USC

Los Angeles, California, United States

Location

Kaiser Permanente Hepatology Research

San Diego, California, United States

Location

University of California, San Diego

San Diego, California, United States

Location

University of California San Francisco

San Francisco, California, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, United States

Location

Unknown Facility

Englewood, Colorado, United States

Location

Unknown Facility

Bardenton, Florida, United States

Location

University of Florida

Gainesville, Florida, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

University Hepatitis Center at Bach & Godofsky

Sarasota, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Gulf Coast Research, LLC

Baton Rouge, Louisiana, United States

Location

Virology Treatment Center, Maine Medical Center

Portland, Maine, United States

Location

Johns Hopkins University

Baltimore, Maryland, United States

Location

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, United States

Location

Henry Ford Hospital

Detroit, Michigan, United States

Location

Saint Louis University

St Louis, Missouri, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

North Shore University Hospital

Manhasset, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

University Internal Medicine Associates, Inc.

Cincinnati, Ohio, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

Unknown Facility

Hershey, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Columbia Gastroenterology Associates, PA

Columbia, South Carolina, United States

Location

Memphis Gastroenterology Group

Germantown, Tennessee, United States

Location

Liver Institute at Methodist Dallas

Dallas, Texas, United States

Location

Advanced Liver Therapies

Houston, Texas, United States

Location

Alamo Medical Research

San Antonio, Texas, United States

Location

Unknown Facility

Annandale, Virginia, United States

Location

Metropolitan Research

Fairfax, Virginia, United States

Location

Unknown Facility

Richmond, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

University of Calgary Medical Clinic - Health Science Centre

Calgary, Alberta, T2N 4N1, Canada

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

BC Hepatitis Program

Vancouver, British Columbia, Canada

Location

Unknown Facility

Winnipeg, Manitoba, Canada

Location

Toronto Western Hospital

Toronto, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Universitatsmedizin Berlin

Berlin, Germany

Location

University Clinic Frankfurt, Department of Internal Medicine

Frankfurt, Germany

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Erasmus MC University Medical Center

Rotterdam, Netherlands

Location

Unknown Facility

Santurce, Puerto Rico

Location

Related Publications (2)

• Li S, Zhu J, Zhang W, Chen Y, Zhang K, Popescu LM, Ma X, Lau WB, Rong R, Yu X, Wang B, Li Y, Xiao C, Zhang M, Wang S, Yu L, Chen AF, Yang X, Cai J. Signature microRNA expression profile of essential hypertension and its novel link to human cytomegalovirus infection. Circulation. 2011 Jul 12;124(2):175-84. doi: 10.1161/CIRCULATIONAHA.110.012237. Epub 2011 Jun 20.

  PMID: 21690488 DERIVED

• McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, Heathcote EJ, Zeuzem S, Reesink HW, Garg J, Bsharat M, George S, Kauffman RS, Adda N, Di Bisceglie AM; PROVE3 Study Team. Telaprevir for previously treated chronic HCV infection. N Engl J Med. 2010 Apr 8;362(14):1292-303. doi: 10.1056/NEJMoa0908014.

  PMID: 20375406 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

telaprevir; Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

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: January 8, 2007
• First Posted: January 11, 2007
• Study Start: February 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: August 5, 2014
• Results First Posted: July 21, 2011

Record last verified: 2014-07

Locations

CA (6); DE (2); US (41); PR (1); NL (3)