An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1

NCT01508130 | Completed Results

• 1 other identifier: ML27900
• Study Type: observational
• Target: 672
• Locations: 2 countries
• Sites: 66

Brief Summary

This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin plus either telaprevir or boceprivir in accordance with local standard of care and US labeling will be followed for the duration of their treatment and for up to 24 weeks post-treatment.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (2)

• Time to Premature Treatment Discontinuation Due to Any Reason

  Time to premature treatment discontinuation for any reason (weeks) was calculated as follows: date of treatment discontinuation for any reason - first treatment administration date + 1/7. The estimated survivorship curves were obtained from Kaplan-Meier maximum likelihood estimates for each treatment group. Participants who completed the study treatment (including those who shorten the treatment based on response-guided therapy) were censored on their last dosing date.

  Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)

• Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period

  SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period

  12 weeks or later post-completion of the treatment period

Secondary Outcomes (18)

• Number of Participants With Virologic Response (VR)

  Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period

• Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above

  Weeks 2, 4, 8, and 12

• Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder

  Up to Week 48

• Predictors of Sustained Virologic Response by Week

  Weeks 2, 4, 6, 8, and 12

• Number of Participants With SVR by Subgroups (Demographic and Baseline Factors)

  Week 12

Study Arms (1)

Cohort

Eligibility Criteria

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

Study Population

Patients with chronic hepatitis C genotype 1 receiving pegylated interferon-based direct acting antiviral triple therapies in the US

You may qualify if:

• Adult patients, \>/= 18 years of age
• Chronic hepatitis C, genotype 1
• Receiving pegylated interferon-based direct acting antiviral therapy (pegylated interferon and ribavirin plus either telaprevir or boceprivir) in accordance with local standard of care and US labeling

You may not qualify if:

• Contraindications per US labels

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (66)

Cooper Green Hospital

Birmingham, Alabama, 35233, United States

Location

Univ. of Alabama at Birmingham; The Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

Liver Wellness Center

Little Rock, Arkansas, 72205, United States

Location

Loma Linda University Medical Center and Liver Center

Loma Linda, California, 92354, United States

Location

HMRI Liver Center

Pasadena, California, 91105, United States

Location

Kaiser Permanente San Diego; Hepatology Research

San Diego, California, 92154, United States

Location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

South Bay Gastroenterology Medical Group

Torrance, California, 90505, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Litchfield County Gastroenterology Associates

Torrington, Connecticut, 06790, United States

Location

Consultive Medicine

Daytona Beach, Florida, 32117, United States

Location

Florida Center for Gastroenterology

Largo, Florida, 33777, United States

Location

Center for Advanced Gastroenterology

Maitland, Florida, 32751, United States

Location

Internal Medicine Specialists

Orlando, Florida, 32806, United States

Location

Orlando Infectious Disease Center, Pa

Orlando, Florida, 32806, United States

Location

Tampa General Hospital; Tampa General Medical Group

Tampa, Florida, 33606, United States

Location

Atlanta Center for Gastroenterology, PC

Decatur, Georgia, 30033, United States

Location

Dekalb Gastroenterology Associates

Decatur, Georgia, 30033, United States

Location

Gastroenterology Associates of Central Georgia

Macon, Georgia, 31201, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indianapolis Gastroenterology

Indianapolis, Indiana, 46237, United States

Location

Tristate Gastroenerology Associates

Crestview Hills, Kentucky, 41017, United States

Location

Ochsner Clinic Foundation

Baton Rouge, Louisiana, 70809, United States

Location

New Orleans Research Institute.

Metairie, Louisiana, 70006, United States

Location

Tulane Uni Health Sciences Center

New Orleans, Louisiana, 70112-2699, United States

Location

Mercy Medical Center; Institute For Digestive Health And Liver Disease

Baltimore, Maryland, 21202, United States

Location

Commonwealth Clinical Studies

Brockton, Massachusetts, 02302, United States

Location

Baystate Infectious Diseases Clinical Research

Springfield, Massachusetts, 01199, United States

Location

Partners in Internal Medicine

Worcester, Massachusetts, 01068, United States

Location

Harper University Hospital/Wayne State

Detroit, Michigan, 48201, United States

Location

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, 49519, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Midwest Biomedical Research Foundation

Kansas City, Missouri, 64128, United States

Location

Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit

St Louis, Missouri, 63104, United States

Location

Dartmouth Hitchcock Med Center

Lebanon, New Hampshire, 03756, United States

Location

Lourdes Medical Associates; Southern New Jersey Center for LIver Disease

Haddon Heights, New Jersey, 08035, United States

Location

Atlantic Research Affiliates

Morristown, New Jersey, 07960, United States

Location

AGA Clinical Research Associates, LLC

Twp, New Jersey, 08234, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Mountainview Medical Practice

Catskill, New York, 12414, United States

Location

New Discovery, LLC

Flushing, New York, 11355, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Concorde Medical Group

New York, New York, 10016, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Asheville Gastroenterology Associates, P.A.

Asheville, North Carolina, 28801, United States

Location

Duke Univ Medical Center

Durham, North Carolina, 27710, United States

Location

Boice-Willis Clinic

Rocky Mount, North Carolina, 27804, United States

Location

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Bend Memorial Clinic

Bend, Oregon, 97701, United States

Location

DuBois Regional Medical Center

DuBois, Pennsylvania, 15801, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Albert Einstein Medical Center; Division of Hepatology

Philadelphia, Pennsylvania, 19141, United States

Location

Methodist Heathcare University Hospital

Memphis, Tennessee, 38104, United States

Location

Imtiaz Alam MD, P.A. - Private Practice

Austin, Texas, 78758, United States

Location

Methodist Transplant Physicians

Dallas, Texas, 75203, United States

Location

Univ of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Kelsey Research Foundation

Houston, Texas, 77005, United States

Location

Liver Associates of Texas

Houston, Texas, 77030, United States

Location

Digestive And Liver Disease Consultants, PA

Houston, Texas, 77090, United States

Location

University of Vermont

Burlington, Vermont, 5401, United States

Location

University of Virginia Health System: Gastroenterology at UVA

Charlottesville, Virginia, 22908, United States

Location

Metropolitan Research

Fairfax, Virginia, 22031, United States

Location

Fundacion de Investigacion de Diego

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

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

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 11, 2012
• Study Start: January 31, 2012
• Primary Completion: March 31, 2014
• Study Completion: March 31, 2014
• Last Updated: April 10, 2017
• Results First Posted: February 22, 2016

Record last verified: 2017-03

Locations

PR (1); US (65)