An Observational Study of Pegasys (Peginterferon Alfa-2a) in Combination With Ribavirin in Patients With Chronic Hepatitis C and Compensated Liver Cirrhosis (STANDART)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609049
First received: May 29, 2012
Last updated: July 1, 2015
Last verified: July 2015
  Purpose

This prospective observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with ribavirin in patients with chronic hepatitis C, including patients with compensated liver cirrhosis, in clinical practice. Data will be collected from patients receiving Pegasys and ribavirin during up to 72 weeks of treatment (according to registered indications depending on baseline viral load, genotype and virological response) and a 24-week follow-up.


Condition
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Open-label, Multicenter, Non-comparative, Prospective Observational Study to Evaluate Efficacy and Safety of Combined Ribavirin and Peginterferon Alfa-2a (40 kDa) Therapy in Patients With Chronic Hepatitis C (CHC) and Compensated Liver Cirrhosis in Real Clinical Practice

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response (SVR) rate: Percentage of patients with undetectable HCV RNA 24 weeks after therapy completion [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virologic response rate: Percentage of patients with SVR and negative HCV RNA at Week 4 and 12 (naïve patients) [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Virologic response rate: Percentage of patients with SVR and negative HCV RNA at Week 12 (previously treated patients) [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Virologic response rate: Percentage of patients with SVR and decrease in HCV RNA by >/= log 10 from baseline (previously treated and naïve patients) [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Virologic response rate: Percentage of patients with SVR who had dose reduction of any drug (ribavirin or Pegasys) due to adverse events [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 6.5 years ] [ Designated as safety issue: No ]

Enrollment: 1496
Study Start Date: December 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 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

Patients with chronic hepatitis C and compensated liver cirrhosis initiating treatment with Pegasys and ribavirin

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Serologically confirmed Chronic hepatitis C, HCV RNA detectable
  • Compensated liver cirrhosis (Child-Pugh Class A) included
  • Initiating combined therapy with Pegasys and ribavirin

Exclusion Criteria:

  • HIV co-infection
  • Contraindications for combined therapy according to actual prescribing information
  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: NCT01609049

  Show 55 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01609049     History of Changes
Other Study ID Numbers: ML27851
Study First Received: May 29, 2012
Last Updated: July 1, 2015
Health Authority: Russia: Ministry of Healthcare and Social Development of the Russian Federation

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

ClinicalTrials.gov processed this record on July 27, 2015