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Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)

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ClinicalTrials.gov Identifier: NCT02106156
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This observational study will examine the efficacy and safety of pegylated interferon (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis C (CHC). Quality of care will also be assessed. Approximately 12% of the interferon-treated CHC patient population in Germany is expected to be studied over a period of 5 years.

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

Study Design
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Study Type : Observational
Actual Enrollment : 10228 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Noninterventional Study on the Quality Assurance of the Therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa-2a (Pegasys®) and Ribavirin (e.g. Copegus®) With Main Focus Gastroenterologists - a Project in BNG (Association of German Resident Gastroenterologists), Part III
Study Start Date : January 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Chronic Hepatitis C
Participants with chronic hepatitis C planned for treatment with peginterferon alfa-2a alone or in combination with ribavirin according to routine clinical practice will be observed in this study.
 Drug: Pegylated interferon alfa-2a
Pegylated interferon alfa-2a administered according to corresponding summary of product characteristics (SmPC).
Other Name: Pegasys®

Drug: Ribavirin
Ribavirin administered according to corresponding summary of product characteristics (SmPC).
Other Name: Copegus®


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Rapid Virologic Response (RVR) [ Time Frame: At Week 4 ]
    RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.

  2. Percentage of Participants With Early Virologic Response (EVR) [ Time Frame: At Week 12 ]
    EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.

  3. Percentage of Participants With End of Treatment (EOT) Response [ Time Frame: Up to Week 72 ]
    EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.

  4. Percentage of Participants With Sustained Virologic Response (SVR) [ Time Frame: Up to Week 96 ]
    SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.

  5. Percentage of Participants With Serious Adverse Drug Reactions (SADR) [ Time Frame: Up to Week 96 ]

Secondary Outcome Measures :
  1. Percentage Cumulative Dose of Peginterferon Alfa-2a Received [ Time Frame: Up to Week 96 ]
    Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.

  2. Percentage Cumulative Dose of Ribavirin Received [ Time Frame: Up to Week 96 ]
    Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.

  3. Duration of Peginterferon Alfa-2a Therapy [ Time Frame: Up to Week 72 ]
    Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented.

  4. Percentage of Participants With the Most Frequent Concomitant Medications [ Time Frame: At Baseline (Day 1) ]
    Most frequent concomitant medications were defined as those, which were observed in >1 % of participants.


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:   Non-Probability Sample
Study Population
Patients with CHC treated with peginterferon alfa-2a and ribavirin according to routine clinical practice
Criteria

Inclusion Criteria:

  • 18 years of age or over
  • Clinically diagnosed CHC with detectable virus replication
  • Women of childbearing potential should use adequate contraception. It is important that female participants of childbearing potential and their sexual partners use 2 contraceptive methods at the same time during treatment and 4 months after treatment discontinuation. During this time pregnancy tests have to be performed monthly. Particular attention is also required and pregnancy should be avoided 7 months after treatment discontinuation in female sexual partners of male participants taking ribavirin (Copegus®). Both should use adequate contraception.

Exclusion Criteria:

  • Any contraindications for peginterferon alfa-2a or ribavirin treatment
  • Pregnant or breast-feeding
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): NCT02106156


Locations
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Germany
Herne, Germany, 44623
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02106156    
Other Study ID Numbers: ML21645
First Posted: April 8, 2014    Key Record Dates
Results First Posted: September 23, 2016
Last Update Posted: September 23, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
 Communicable Diseases
Flaviviridae Infections
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