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An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure

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ClinicalTrials.gov Identifier: NCT01798576
Recruitment Status : Terminated
First Posted : February 26, 2013
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. Participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.

Condition or disease Intervention/treatment
Hepatitis C, Chronic Drug: Pegylated Interferon alfa-2a Drug: Ribavirin

Study Design
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Study Type : Observational
Actual Enrollment : 282 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional, Observational Study on Retreatment of Chronic Hepatitis C Patients Previous Treatment Failure, Using Peginterferon Alfa-2a and Ribavirin Based Regimens
Study Start Date : November 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Pegylated interferon alfa-2a
Participants with chronic hepatitis C with previous treatment failure received combination therapy with pegylated interferon alfa-2a plus ribavirin or treatment regimens containing direct-acting anti-viral (DAAs)
 Drug: Pegylated Interferon alfa-2a
Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.
Other Name: Peginterferon alfa 2A

Drug: Ribavirin
Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.


Outcome Measures
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Primary Outcome Measures :
  1. Sustained virological response (SVR) rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks post completion of treatment (overall and stratified by prior treatment outcome: non-response and relapse) [ Time Frame: approximately 3 years ]

Secondary Outcome Measures :
  1. Percentage of patients with rapid virological response (RVR), defined as HCV RNA <50 IU/mL at Week 4 (overall and stratified by prior treatment outcome: non-response and relapse) [ Time Frame: approximately 3 years ]
  2. Percentage of patients with early virological response (EVR), defined as HCV RNA <50 IU/mL or an at least 2-log drop from baseline in HCV RNA at Week 12, but with no RVR (overall and stratified by prior treatment outcome: non-response and relapse) [ Time Frame: approximately 3 years ]
  3. Percentage of patients with non-response/relapse/virological breakthrough/virological rebound [ Time Frame: approximately 3 years ]
  4. Duration of treatment [ Time Frame: approximately 3 years ]
  5. Time to safety-related dose reduction/treatment discontinuation of any of the treatment compounds [ Time Frame: approximately 3 years ]
  6. Safety: Incidence of adverse events [ Time Frame: approximately 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Treatment-experienced participants with chronic hepatitis C receiving re-treatment with Pegasys plus ribavirin or regimens containing direct-acting antivirals (DAAs)
Criteria

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin
  • No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label

  • Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular:

    • Positive serum hepatitis C virus (HCV) ribonucleic acid (RNA)
    • Fertile males and females receiving ribavirin must use two forms of contraception during treatment with Pegasys/ribavirin and until 6 months post-treatment
    • No co-infection with hepatitis B or human immunodeficiency virus (HIV)

Exclusion Criteria:

  • History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
  • History of neurological disease
  • History of severe psychiatric disease
  • Decompensated diabetes
  • History of immunologically mediated disease
  • History of severe cardiac disease
  • History or evidence of severe chronic pulmonary disease
  • Inadequate hematologic function
  • Pregnant or breastfeeding women
  • Male partners of pregnant women
Contacts and Locations
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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): NCT01798576


Locations
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Romania
Brasov, Romania, 500326
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01798576    
Other Study ID Numbers: ML28498
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
 Interferons
Ribavirin
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs