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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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01604291
First received: May 21, 2012
Last updated: November 10, 2014
Last verified: November 2014
  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:


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 ]

Enrollment: 961
Study Start Date: May 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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
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: NCT01604291

Locations
Israel
Afula, Israel, 18101
Ashkelon, Israel, 78278
Beer Sheva, Israel, 84105
Hadera, Israel, 38100
Haifa, Israel, 33394
Haifa, Israel, 34362
Haifa, Israel, 31096
Holon, Israel, 58100
Jerusalem, Israel, 91031
Jerusalem, Israel, 91120
Kfar Saba, Israel, 44281
Nahariya, Israel, 22100
Nazareth, Israel
Petach Tikva, Israel
Petah Tiqwa, Israel
Ramat Gan, Israel, 52620-00
Rehovot, Israel, 76100
Safed, Israel, 13110
Tel Aviv, Israel, 6423906
Tiberias, Israel
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: November 10, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014