An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01392742
First received: July 11, 2011
Last updated: November 9, 2015
Last verified: November 2015
  Purpose
This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.

Condition
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in HCV-infected Patients Receiving Peginterferon Alfa-2a Plus Ribavirin

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virological Response (SVR) [ Time Frame: 24 weeks after End of treatment (EOT) (up to Week 96) ] [ Designated as safety issue: No ]
    SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction [PCR] measured greater than or equal to >=140 days post-treatment).

  • Percentage of Participants With Relapse [ Time Frame: Up to 24 weeks after EOT (up to Week 96) ] [ Designated as safety issue: No ]
    Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.

  • Percentage of Participants Who Were Non-Responders [ Time Frame: Up to 24 weeks after EOT (up to Week 96) ] [ Designated as safety issue: No ]
    Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.


Secondary Outcome Measures:
  • Percentage of Participants With Positive Predictive Value on SVR at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/(number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.

  • Percentage of Participants With Positive Predictive Value on SVR at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/( number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.

  • Correlation of SVR With Rapid Virological Response (RVR) [ Time Frame: Up to 24 weeks after EOT (up to Week 96) ] [ Designated as safety issue: No ]
    Correlation of SVR with RVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment.

  • Correlation of SVR With Early Virological Response (EVR) [ Time Frame: Up to 24 weeks after EOT (up to Week 96) ] [ Designated as safety issue: No ]
    Correlation of SVR with EVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.

  • Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response [ Time Frame: Week 4 and 12 ] [ Designated as safety issue: No ]
    Predictive value determined the relationship of host factors to virological response. Host factors included; RVR (EVR for Week 12), gender, liver fibrosis, HCV genotype, height and treatment duration for Week 4 after EOT excluding HCV genotype at Week 12 EOT. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment and EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.

  • Duration of Treatment in Participants With SVR by HCV Genotype [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.

  • Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.

  • Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype [ Time Frame: Up to Week 72 ] [ Designated as safety issue: No ]
    SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.

  • Percentage of Participants With Virological Response [ Time Frame: 4 weeks after EOT (up to Week 76) ] [ Designated as safety issue: No ]
    The Virological response at the end of treatment was defined as the percentage of participants with undetectable HCV RNA, HCV test (based on a single last undetectable HCV RNA PCR falling in the 4 weeks' time window at end of treatment), is basically the sum of participants with SVR and with relapse.


Enrollment: 443
Study Start Date: May 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic hepatitis C treated with Pegasys and ribavirin
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Serologically confirmed chronic hepatitis C (all genotypes)
  • Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling

Exclusion Criteria:

  • Coinfection with HIV and/or hepatitis B
  • Contraindications according to the SPC for Pegasys/ribavirin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392742

Locations
Bulgaria
Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4002
Sofia, Bulgaria, 1407
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1612
Stara Zagora, Bulgaria, 6000
Varna, Bulgaria, 9010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01392742     History of Changes
Other Study ID Numbers: ML25670 
Study First Received: July 11, 2011
Results First Received: November 9, 2015
Last Updated: November 9, 2015
Health Authority: Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 30, 2016