This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01604291
First received: May 21, 2012
Last updated: February 15, 2017
Last verified: February 2017
  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 ]

Secondary Outcome Measures:
  • Dual versus triple Pegasys-based therapy: SVR-24 rates [ Time Frame: approximately 4.5 years ]
  • Correlation between SVR-24 and clinical/demographic baseline values [ Time Frame: approximately 4.5 years ]
  • 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 ]
  • Treatment duration [ Time Frame: approximately 4.5 years ]
  • Dose reductions/treatment discontinuations [ Time Frame: approximately 4.5 years ]
  • Correlation between dose reductions/treatment interruptions and sustained virological response (SVR) [ Time Frame: approximately 4.5 years ]
  • Safety: Incidence of adverse events (dual versus triple therapy) [ Time Frame: approximately 4.5 years ]
  • Rate of treatment-induced anemia (dual versus triple therapy) [ Time Frame: approximately 4.5 years ]
  • Treatment regimens for HCV treatment induced anemia in routine clinical practice [ Time Frame: approximately 4.5 years ]
  • Rate of virological relapse [ Time Frame: approximately 4.5 years ]

Enrollment: 959
Study Start Date: May 2012
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Haemek Hospital; Gastroenterology
Afula, Israel, 18101
Barzilai MC; Gastroenterology
Ashkelon, Israel, 78278
Soroka Medical Center; Gastroenterology
Beer Sheva, Israel, 84105
Hillel Yaffe Hospital; Gastroenterology
Hadera, Israel, 38100
Rambam Medical Center; Gastroenterology - Liver Unit
Haifa, Israel, 31096
Bnei-Zion Medical Center; Gastroenterology
Haifa, Israel, 33394
Carmel Hospital; Liver Unit
Haifa, Israel, 34362
Wolfson Hospital; Gastroenterology Unit
Holon, Israel, 58100
Shaare Zedek Hospital Liver Unit; Liver Unit
Jerusalem, Israel, 91031
Hadassah Hospital; Liver Unit
Jerusalem, Israel, 91120
Meir Medical Center; Liver Unit
Kfar Saba, Israel, 44281
Western Galilee Hospital - Nahariya
Nahariya, Israel, 22100
Holy Family Medical Center; Liver Unit
Nazareth, Israel
Hasharon Mc; Gastroenterology
Petach Tikva, Israel
Beilinson-Rabin Liver Unit; Liver Unit
Petah Tiqwa, Israel
Sheba Medical Center; Tel Hashomer
Ramat Gan, Israel, 5262100
Kaplan Medical Center; Gastroenterology Unit
Rehovot, Israel, 76100
Rebecca Sieff Medical Center; Liver Unit
Safed, Israel, 13110
Tel-Aviv Sourasky Medical Center; Liver Unit
Tel Aviv, Israel, 6423906
Poria Hospital; Gastroenterology
Tiberias, Israel
Assaf Harofeh; Gastroenterology
Zerifin, Israel, 6093000
Sponsors and Collaborators
Hoffmann-La Roche
Clalit Health Services
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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: February 15, 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
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

ClinicalTrials.gov processed this record on June 27, 2017