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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392742
• Other study ID #: ML25670
• Status: Completed
• Phase: N/A
• First received: July 11, 2011
• Last updated: November 9, 2015
• Start date: May 2011
• Est. completion date: July 2014

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virological Response (SVR)	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).	24 weeks after End of treatment (EOT) (up to Week 96)	No
Primary	Percentage of Participants With Relapse	Relapse was define as ?n undetectable HCV RNA during the treatment period, but without such during the follow-up.	Up to 24 weeks after EOT (up to Week 96)	No
Primary	Percentage of Participants Who Were Non-Responders	Non-responders were those participants who had not reached ?n undetectable HCV RNA during the treatment period.	Up to 24 weeks after EOT (up to Week 96)	No
Secondary	Percentage of Participants With Positive Predictive Value on SVR at Week 4	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.	Week 4	No
Secondary	Percentage of Participants With Positive Predictive Value on SVR at Week 12	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.	Week 12	No
Secondary	Correlation of SVR With Rapid Virological Response (RVR)	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.	Up to 24 weeks after EOT (up to Week 96)	No
Secondary	Correlation of SVR With Early Virological Response (EVR)	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.	Up to 24 weeks after EOT (up to Week 96)	No
Secondary	Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response	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.	Week 4 and 12	No
Secondary	Duration of Treatment in Participants With SVR by HCV Genotype	SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.	Up to Week 72	No
Secondary	Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype	SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.	Up to Week 72	No
Secondary	Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype	SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.	Up to Week 72	No
Secondary	Percentage of Participants With Virological Response	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.	4 weeks after EOT (up to Week 76)	No