Clinical trial 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)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 10228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CHC treated with peginterferon alfa-2a and ribavirin according to routine clinical practice

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Rapid Virologic Response (RVR)
timeFrame: At Week 4
measure: Percentage of Participants With Early Virologic Response (EVR)
timeFrame: At Week 12
measure: Percentage of Participants With End of Treatment (EOT) Response
timeFrame: Up to Week 72
measure: Percentage of Participants With Sustained Virologic Response (SVR)
timeFrame: Up to Week 96
measure: Percentage of Participants With Serious Adverse Drug Reactions (SADR)
timeFrame: Up to Week 96
Secondary outcomes:
measure: Percentage Cumulative Dose of Peginterferon Alfa-2a Received
timeFrame: Up to Week 96
measure: Percentage Cumulative Dose of Ribavirin Received
timeFrame: Up to Week 96
measure: Duration of Peginterferon Alfa-2a Therapy
timeFrame: Up to Week 72
measure: Percentage of Participants With the Most Frequent Concomitant Medications
timeFrame: At Baseline (Day 1)
Other outcomes:
Locations:
city: Herne
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Niederau C, Mauss S, Schober A, Stoehr A, Zimmermann T, Waizmann M, Moog G, Pape S, Weber B, Isernhagen K, Sandow P, Bokemeyer B, Alshuth U, Steffens H, Huppe D. Predictive factors for sustained virological response after treatment with pegylated interferon alpha-2a and ribavirin in patients infected with HCV genotypes 2 and 3. PLoS One. 2014 Sep 19;9(9):e107592. doi: 10.1371/journal.pone.0107592. eCollection 2014.