Text Size

PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01066819
First received: February 9, 2010
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa-2b and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <2000.


Condition Intervention
Hepatitis C, Chronic
 Drug: peginterferon alfa-2a [Pegasys]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Predictive values of virological response 4 and 12 weeks after treatment initiation on sustained virological response (SVR) by HCV genotype [ Time Frame: weeks 4 and 12, and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification and confirmation of host-, virus- and treatment-related factors influencing viral response, SVR and relapse [ Time Frame: throughout treatment and 12 and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Correlation between overall treatment duration/treatment duration after HCV RNA becomes negative and SVR by genotype [ Time Frame: assessed 12 and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Correlation of cumulative ribavirin and peginterferon dose with SVR by genotype [ Time Frame: assessed 12 and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]

Enrollment: 1611
Study Start Date: January 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Drug: peginterferon alfa-2a [Pegasys]
As prescribed by physician

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients receiving peginterferon alfa treatment at a medical centre

Criteria

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • chronic hepatitis C
  • HIV HCV co-infection allowed
  • informed consent to data collection

Exclusion Criteria:

  • co-infection with HBV
  • previous treatment with peginterferon and/or ribavirin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066819

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
Birmingham, Alabama, United States, 35294
Birmingham, Alabama, United States, 35249
Dothan, Alabama, United States, 36305
United States, California
Fresno, California, United States, 93721
La Jolla, California, United States, 92037-1030
Lancaster, California, United States, 93534
Loma Linda, California, United States, 92354
Long Beach, California, United States, 90822
Los Angeles, California, United States, 90095
Los Angeles, California, United States, 90057
Los Angeles, California, United States, 90048
Sacramento, California, United States, 95817
San Clemente, California, United States, 92679
San Diego, California, United States, 92103-8465
San Francisco, California, United States, 94115
San Mateo, California, United States, 94403
Torrance, California, United States, 90505
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Hartford, Connecticut, United States, 06106
United States, Florida
Gainesville, Florida, United States, 32610-0214
Maitland, Florida, United States, 32751
Orlando, Florida, United States, 32803
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta, Georgia, United States, 30308
Decatur, Georgia, United States, 30033
Macon, Georgia, United States, 31201
Marietta, Georgia, United States, 30060
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Chicago, Illinois, United States, 60637
Chicago, Illinois, United States, 60612
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Lexington, Kentucky, United States, 40536-0298
United States, Louisiana
Baton Rouge, Louisiana, United States, 70890
New Orleans, Louisiana, United States, 70121
Opelousas, Louisiana, United States, 70520
United States, Maryland
Annapolis, Maryland, United States, 21401
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Springfield, Massachusetts, United States, 01107-1635
Springfield, Massachusetts, United States, 01103
Worcester, Massachusetts, United States, 01068
United States, Michigan
Detroit, Michigan, United States, 48201
Grand Rapids, Michigan, United States, 49506
United States, Mississippi
Jackson, Mississippi, United States, 39202
Tupelo, Mississippi, United States, 38801
United States, Missouri
St Louis, Missouri, United States, 63110
St Louis, Missouri, United States, 63104
Topeka, Missouri, United States, 66606
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Egg Harbour Township, New Jersey, United States, 08234
Hackensack, New Jersey, United States, 07601
Hillsborough, New Jersey, United States, 08844
Roseland, New Jersey, United States, 07068
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Bayside, New York, United States, 11358
Catskill, New York, United States, 12414
Flushing, New York, United States, 11355
New York, New York, United States, 10003
New York, New York, United States, 10016
Poughkeepsie, New York, United States, 12601
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville, North Carolina, United States, 28801
Chapel Hill, North Carolina, United States, 27599-7080
Charlotte, North Carolina, United States, 28211
Fayetteville, North Carolina, United States, 28304
Rocky Mount, North Carolina, United States, 27804
Winston-salem, North Carolina, United States, 27103
Winston-salem, North Carolina, United States, 27157
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44106
Cleveland, Ohio, United States, 44109
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112-4481
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Medford, Oregon, United States, 97504
Portland, Oregon, United States, 97239
Portland, Oregon, United States, 97227
United States, Pennsylvania
Camp Hill, Pennsylvania, United States, 17011
Dubois, Pennsylvania, United States, 15801
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Bristol, Tennessee, United States, 37620
Chattanooga, Tennessee, United States, 37403
Germantown, Tennessee, United States, 38138
Kingsport, Tennessee, United States, 37660
Nashville, Tennessee, United States, 37203
West Nashville, Tennessee, United States, 37205
United States, Texas
Dallas, Texas, United States, 75203
Fort Sam Houston, Texas, United States, 78234-3879
Galveston, Texas, United States, 77555
Harlingen, Texas, United States, 78550
Houston, Texas, United States, 77074
Houston, Texas, United States, 77030
Houston, Texas, United States, 77090
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84121
United States, Virginia
Charlottesville, Virginia, United States, 22908
Fairfax, Virginia, United States, 22031
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23298
United States, Washington
Seattle, Washington, United States, 98133
United States, West Virginia
Huntington, West Virginia, United States, 25701
United States, Wyoming
Casper, Wyoming, United States, 82609
Puerto Rico
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01066819     History of Changes
Other Study ID Numbers: MV21542
Study First Received: February 9, 2010
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Interferon-alpha
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013