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An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01604291
First received: May 21, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.


Condition
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Center, Non-Interventional Study, on the Efficacy of Dual and Triple Therapies Based on Pegylated Interferon Alfa-2a for the Treatment of Chronic Hepatitis C Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained Virological Response (SVR)-24 rate: Percentage of patients with HCV RNA <50 IU/mL at 24 weeks post completion of treatment [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dual versus triple Pegasys-based therapy: SVR-24 rates [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Correlation between SVR-24 and clinical/demographic baseline values [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Predictive value of on-treatment factors (RVR, eRVR, EVR, EOT) on virological response (HCV-RNA <50 IU/mL): Percentage of patients with rapid/rapid extended/early/end of treatment response [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Treatment duration [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Dose reductions/treatment discontinuations [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Correlation between dose reductions/treatment interruptions and sustained virological response (SVR) [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events (dual versus triple therapy) [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Rate of treatment-induced anemia (dual versus triple therapy) [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Treatment regimens for HCV treatment induced anemia in routine clinical practice [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Rate of virological relapse [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Chronic hepatitis C patients initiating Pegasys-based treatment

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
  • Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
  • No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
  • Quantitative serum HCV RNA by PCR test before initiation of treatment

Exclusion Criteria:

  • Hepatitis A/B co-infection
  • Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Pregnant or breast-feeding women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604291

Contacts
Contact: Please reference Study ID Number: ML28268 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Israel
Not yet recruiting
Ashdod, Israel, 77444
Recruiting
Ashkelon, Israel, 78278
Not yet recruiting
Bat Yam, Israel
Recruiting
Beer Sheva, Israel, 84105
Not yet recruiting
Hadera, Israel, 38100
Recruiting
Haifa, Israel, 34362
Recruiting
Haifa, Israel, 33394
Recruiting
Haifa, Israel, 31096
Recruiting
Holon, Israel, 58100
Recruiting
Jerusalem, Israel, 91031
Not yet recruiting
Jerusalem, Israel
Recruiting
Kfar Saba, Israel, 44281
Recruiting
Nahariya, Israel, 22100
Recruiting
Petach Tikva, Israel
Recruiting
Petah Tiqwa, Israel
Recruiting
Ramat Gan, Israel, 52621
Recruiting
Rehovot, Israel, 76100
Recruiting
Safed, Israel, 13110
Recruiting
Tel Aviv, Israel, 64239
Recruiting
Tiberias, Israel
Recruiting
Zerifin, Israel, 70300
Sponsors and Collaborators
Hoffmann-La Roche
Clalit Health Services
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01604291     History of Changes
Other Study ID Numbers: ML28268
Study First Received: May 21, 2012
Last Updated: May 7, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013