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)

NCT02106156 | Completed Results

• 1 other identifier: ML21645
• Study Type: observational
• Target: 10,228
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Rapid Virologic Response (RVR)

  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.

  At Week 4

• Percentage of Participants With Early Virologic Response (EVR)

  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.

  At Week 12

• Percentage of Participants With End of Treatment (EOT) Response

  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.

  Up to Week 72

• Percentage of Participants With Sustained Virologic Response (SVR)

  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.

  Up to Week 96

• Percentage of Participants With Serious Adverse Drug Reactions (SADR)

  Up to Week 96

Secondary Outcomes (4)

• Percentage Cumulative Dose of Peginterferon Alfa-2a Received

  Up to Week 96

• Percentage Cumulative Dose of Ribavirin Received

  Up to Week 96

• Duration of Peginterferon Alfa-2a Therapy

  Up to Week 72

• Percentage of Participants With the Most Frequent Concomitant Medications

  At Baseline (Day 1)

Study Arms (1)

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; Drug: Ribavirin

Interventions

Pegylated interferon alfa-2a DRUG

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

Also known as: Pegasys®

Chronic Hepatitis C

Ribavirin DRUG

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

Also known as: Copegus®

Chronic Hepatitis C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CHC treated with peginterferon alfa-2a and ribavirin according to routine clinical practice

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Herne, 44623, Germany

Location

Related Publications (1)

• 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.

  PMID: 25238535 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: January 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 23, 2016
• Results First Posted: September 23, 2016

Record last verified: 2016-08

Locations

DE (1)