An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01447446
• Date of registration: 04/10/2011
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
• Scientific title: Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C
• Date of first enrolment: September 2011
• Target sample size: 4442
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01447446
• Study type: Observational
• Phase: N/A

Countries of recruitment

Belgium, Egypt, Estonia, France, Germany, Greece, Hungary, India, Ireland, Italy, Kuwait, Lebanon, Macedonia, The Former Yugoslav Republic of, Morocco, Oman, Pakistan, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Turkey, United Arab Emirates, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult (according to local legislation) participants

- Chronic hepatitis C (HCV)

- Naive or treatment experienced, HIV-HCV co-infected or HCV mono-infected

- Receiving treatment for HCV with pegylated interferons plus ribavirin or regimens
containing direct-acting antivirals (DAA) according to standard of care and in line
with current SPC/local labeling

Exclusion Criteria:

- Contraindications according to SPC/local labeling

- Treatment started >4 weeks before entering study



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis C, Chronic

Intervention(s)

Drug: Ribavirin

Drug: Boceprevir

Drug: Peg-IFN Alfa-2a

Drug: Peg-IFN Alfa-2b

Drug: Telaprevir

Primary Outcome(s)

Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) [Time Frame: 12 weeks after end of treatment (up to 118 weeks)]

Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) [Time Frame: 24 weeks after end of treatment (up to 118 weeks)]

Secondary Outcome(s)

Duration of Overall Treatment [Time Frame: Up to 118 weeks]

Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC) [Time Frame: Up to 118 weeks]

Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV) [Time Frame: Up to 72 weeks of treatment]

Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR) [Time Frame: Up to 98 weeks]

Virological Relapse After End of Treatment [Time Frame: Up to 24 weeks after EOT (up to 118 weeks)]

Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions [Time Frame: Up to first 12 weeks of treatment]

Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks [Time Frame: Up to 12 weeks]

Virological Response at Various on Treatment Time Points and End of Treatment (EOT) [Time Frame: Week 4, 12 and End of treatment (EOT) (up to 96 weeks)]

Virological Breakthrough [Time Frame: Up to EOT (up to 118 weeks)]

Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA) [Time Frame: Up to 72 weeks of treatment]

Percentage of Participants With Concomitant Medical Condition at Baseline [Time Frame: Baseline]

Percentage of Participants With Adverse Events (AE) [Time Frame: Up to 118 weeks]

Secondary ID(s)

MV25599

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01447446