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Trial record 63 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

A Study of Peginterferon Alfa-2a Plus Ribavirin in Early Non-Responder Participants With Chronic Hepatitis C (CHC) Genotype 1, 4, 5, and 6

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ClinicalTrials.gov Identifier: NCT02791256
Recruitment Status : Terminated
First Posted : June 6, 2016
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6 CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin. The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24 weeks).

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Ribavirin Drug: peginterferon alfa-2a Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Pilot Study of Dose Escalation of PEGASYS on Virological Response in Patients With Chronic Hepatitis C Viral Infection Showing an Early Non-response to a Standard Course of PEGASYS Plus Ribavirin
Study Start Date : June 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peginterferon Alfa-2a + Ribavirin
Participants will receive 360 microgram (mcg) of Peginterferon Alfa-2a subcutaneous (SC) once a week plus ribavirin (1000 - 1200 milligram per day [mg/day] orally as a split dose in the morning and the evening based on the participant's body weight) for 32 weeks.
Drug: Ribavirin
Other Name: Copegus, Ro 20-9963

Drug: peginterferon alfa-2a
Other Name: Pegasys, Ro 25-8310




Primary Outcome Measures :
  1. Percentage of Participants Achieving Virologic Response, as measured by ultrasensitive Roche HCV TaqMan Test [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Percentage of Participants Achieving Sustained Virologic Response (SVR), as measured by ultrasensitive Roche HCV TaqMan Test [ Time Frame: Week 56 ]
  2. Percentage of Participants Achieving End-of-treatment Response, as measured by ultrasensitive Roche HCV TaqMan Test [ Time Frame: Week 32 ]
  3. Mean Log Change From Baseline to Week 2, 4, 8, 12, 32, and 56 in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Viral Load [ Time Frame: Baseline, Week 2, 4, 8, 12, 32, 56 ]
  4. Number of Participants With Adverse Events and Serious Adverse [ Time Frame: Baseline up to Week 56 ]


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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:

  • Participants with serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
  • Participants had to have been receiving their first treatment for chronic hepatitis C (i.e. previously naive to any therapy) consisting of peginterferon alfa-2a plus ribavirin for 16 weeks (+/- 10 days), without reaching a negative or 2-log drop of Serum Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at Week 12 of therapy as compared to pretreatment value, and must still be on therapy (no wash out)
  • HCV-RNA quantifiable by a test reporting in international units
  • Compensated liver disease (Child-Pugh Grade A clinical classification)
  • Participants with cirrhosis or transition to cirrhosis had to have an abdominal ultrasound, computerized tomography (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma and a serum alpha fetoprotein (AFP) less than (<)100 nanogram pe milliliter (ng/mL) within 6 months of study entry
  • Negative urine or blood pregnancy test
  • Participants had to be using two forms of effective contraception during treatment and during the 6 months after treatment end
  • Able to participate and to comply with the study restrictions

Exclusion Criteria:

  • Women with ongoing pregnancy or who are breast feeding and male partners of women who were pregnant
  • Neutrophil count <1,500 cells/cubic millimeter (mm^3) or platelet count <90,000 cells/mm^3 before initiation of the ongoing treatment regimen; or neutrophil count <750 cells/mm^3 or platelet count <50,000 cells/mm^3 at screening while still on therapy with peginterferon alfa-2a plus ribavirin
  • Hemoglobin (Hgb) <12 gram per deciliter (g/dL) before initiation of the ongoing treatment regimen; or Hgb <10 g/dL at screening while still on therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
  • Serum creatinine level greater than (>)1.5 times the upper limit of normal at screening
  • Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) other than the currently failing Pegasys plus ribavirin combination therapy less than or equal to (<=) 6 months prior to the first dose of study drug
  • Positive test for hepatitis A immunoglobulin M (IgM) antibody (anti-HAV IgM Ab), hepatitis B surface antigen (HBsAg), anti-hepatitis B core IgM antibody (anti-HBc IgM Ab), anti-Human Immunodeficiency Virus antibody (anti-HIV Ab)
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV
  • History of bleeding from esophageal varices or other conditions consistent with decompensated liver disease, severe psychiatric disease (especially depression), severe seizure disorder, thyroid disease, immunologically mediated disease, chronic pulmonary disease, cardiac disease, major organ transplantation or other evidence of severe illness, malignancy
  • Evidence of drug abuse including excessive alcohol consumption

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): NCT02791256


Locations
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Belgium
Antwerpen, Belgium, 2018
Antwerpen, Belgium, 2060
Brugge, Belgium, 8000
Bruxelles, Belgium, 1000
Bruxelles, Belgium, 1020
Bruxelles, Belgium, 1070
Bruxelles, Belgium, 1090
Bruxelles, Belgium, 1180
Bruxelles, Belgium, 1190
Bruxelles, Belgium, 1200
Charleroi, Belgium, 6000
Edegem, Belgium, 2650
Gent, Belgium, 9000
Gilly, Belgium, 6060
Haine-saint-paul, Belgium, 7100
Kortrijk, Belgium, 8500
Leuven, Belgium, 3000
Liege, Belgium, 4000
Namur, Belgium, 5000
Roeselare, Belgium, 8800
Yvoir, Belgium, 5530
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02791256     History of Changes
Other Study ID Numbers: ML18232
2005-000198-22 ( EudraCT Number )
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Peginterferon alfa-2a
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs