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Completed

NCT Number: NCT02106156

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)

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herne, 44623, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegylated interferon alfa-2a

Drug

Pegylated interferon alfa-2a administered according to corresponding summary of product characteristics (SmPC).

Other names: Pegasys®

Ribavirin

Drug

Ribavirin administered according to corresponding summary of product characteristics (SmPC).

Other names: Copegus®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Apr 8, 2014
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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