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EXtended Therapy in Hepatitis C Genotype 3 Infected Patients (EXACT-R(3))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01095445
Recruitment Status : Terminated (Unlikely to recruit the adequate number of patients within a reasonable timeline)
First Posted : March 30, 2010
Last Update Posted : September 29, 2011
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
The purpose of this study is to evaluate the effect of 48 vs 24 weeks of treatment with Peginterferon alfa-2b plus weight-based ribavirin on Sustained Virologic Response (SVR) and relapse rates in patients infected with genotype 3 chronic hepatitis C (CHC) who do not achieve a Rapid Virologic Response (RVR) but attain a complete Early Virologic Response (cEVR).

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Peginterferon alfa-2b (Pegetron) plus ribavirin (Rebetol) Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EXtended Therapy in Genotype 3 Infected Patients Who do Not AChieve a Treatment Response at Week 4 (RVR) But do Achieve a Complete Early Virologic Response (cEVR)
Study Start Date : February 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of care treatment
Participants will be randomized to receive only the standard 24 weeks of therapy (Peginterferon alfa-2b plus ribavirin).
Active Comparator: Extended therapy
Participants will be randomized to receive 24 weeks of therapy (Peginterferon alfa-2b plus ribavirin) in addition to their standard of care therapy.
Drug: Peginterferon alfa-2b (Pegetron) plus ribavirin (Rebetol)
Dosage Form: Pegetron - powder for solution; Rebetol - capsules Strength: Pegetron Redipen - 120 mcg per pen; Rebetol - 200 mg Route of Administration: Pegetron - subcutaneous; Rebetol - oral
Other Names:
  • Pegetron
  • Rebetol




Primary Outcome Measures :
  1. End of treatment response [ Time Frame: 24 weeks following end of therapy ]
    Undetectable hepatitis C virus (HCV) RNA at 24 weeks following end of therapy


Secondary Outcome Measures :
  1. Relapse rate [ Time Frame: 24 weeks following end of therapy ]
    Undetectable HCV RNA at end of treatment but detectable HCV RNA at 24 weeks following end of therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infected with only genotype 3, hepatitis C
  • Treatment naïve before current course of therapy
  • A positive HCV RNA test result at Week 4 (no RVR)
  • A negative HCV RNA test result at Week 12 (cEVR)
  • A recent liver biopsy (within 3 years prior to study entry) is required. If the patient has either liver biopsy proven cirrhosis in the past or has splenomegaly with features of cirrhosis on ultrasound and/or thrombocytopenia (<150x109/ml) at any time in the past or has a Fibroscan reading of 10 or above or has a Fibrotest score of 0.75 or above (equivalent to F3 on the METAVIR scale), a biopsy will not be required. A copy of the latest report must be available.

Exclusion Criteria:

  • Under age 18
  • Co-infection with HIV or Hepatitis B or any other HCV genotype in addition to genotype 3
  • Prior treatment for Hepatitis C aside from herbal remedies
  • Evidence of decompensated liver disease, such as ascites, bleeding varices, hepatic encephalopathy or jaundice (conjugated hyperbilirubinemia)
  • INR > 1.3 at baseline
  • Platelet count <70 X 109/μl at baseline
  • Those subjects with diabetes and/or systemic hypertension will need to have ocular examinations (as per standard of care [SOC]) prior to treatment and will be excluded if they are found to have a diabetic retinopathy, optic nerve disorders, retinal hemorrhage or any other clinically significant abnormality
  • Pre-existing psychiatric conditions including:

    • Current moderate or severe depression despite appropriate therapy.
    • Active suicidal ideation or previous attempt at suicide
    • Patients with a history of severe psychiatric disorder (may be included if so desired by the investigator but pretreatment psychiatric evaluation is required (SOC)).
    • Clinical diagnosis of current substance abuse: Alcohol (>40g/d), injection drugs, inhalational drugs (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over the counter drugs within one year of the screening visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095445


Locations
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Canada, Alberta
Calgary Heart Centre
Calgary, Alberta, Canada, T2N 4Z6
Hys Med Centre
Edmonton, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Liver and Intestinal Research Centre
Vancouver, British Columbia, Canada, V5Z 1H2
Dr. John D Farley Medical Office
Vancouver, British Columbia, Canada, V6A 4B6
Pacific Gastroenterology Assoc
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Dr. Dalia El-Ashry clinic
Mississauga, Ontario, Canada, L5B 2V2
Credit Valley Med Arts Centre
Mississauga, Ontario, Canada, L5M2V8
Toronto General Hospital - Dr. M. Sherman
Toronto, Ontario, Canada, M5G 2C4
Toronto Western Hospital - Liver Clinic
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
SMBD Jewish Gen Hosp
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
University Health Network, Toronto
Schering-Plough
Investigators
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Principal Investigator: E. Jenny Heathcote, MB,BS,MD,FRCP,FRCP(C) University Health Network - Toronto Western Hospital

Publications:

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01095445     History of Changes
Other Study ID Numbers: EXACT-R(3)
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: September 29, 2011
Last Verified: March 2010

Keywords provided by University Health Network, Toronto:
hepatitis C
genotype 3
end of treatment response
relapse rate
rapid virologic response
complete early virologic response

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs