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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609049
First received: May 29, 2012
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
This prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including participants with compensated liver cirrhosis, in clinical practice.

Condition Intervention
Hepatitis C, Chronic Drug: Peginterferon alfa-2a Drug: Ribavirin

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) or Compensated Liver Cirrhosis in Real Clinical Practice

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (less than [<] 50 International Units per Milliliter [IU/mL]) 24 Weeks Post Therapy Completion [ Time Frame: Baseline up to 24 Weeks Post Therapy Completion (approximately 3.5 years) ]

Secondary Outcome Measures:
  • Percentage of Naive Participants With Sustained Virological Response (SVR)) and Negative HCV RNA (< 50 IU/mL) at Week 4 and 12 [ Time Frame: Week 4, 12 ]
  • Percentage of Previously Treated Participants With SVR and Negative HCV RNA (< 50 IU/mL) at Week 12 [ Time Frame: Week 12 ]
  • Percentage of Previously Treated Participants With SVR and Decrease in HCV RNA by Greater Than or Equal to (>/=) 2 Logarithm 10 From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percentage of Naive Participants With SVR and Decrease in HCV RNA by >/= 2 Logarithm 10 From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percentage of Previously Treated Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24 [ Time Frame: Week 24 ]
  • Percentage of Naive Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24 [ Time Frame: Week 24 ]
  • Percentage of Participants With SVR and Dose Reduction of Ribavirin or Peginterferon alfa-2a due to Adverse Event [ Time Frame: Baseline up to approximately 3.5 years ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 3.5 years ]

Enrollment: 1496
Actual Study Start Date: December 7, 2011
Study Completion Date: June 22, 2015
Primary Completion Date: June 22, 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants with Chronic Hepatitis C
Naive and previously treated participants who received peginterferon alfa-2a in combination with ribavirin as per local labeling requirements.
Drug: Peginterferon alfa-2a
Administration of treatment will be according to local recommendation under local labeling.
Other Name: Pegasys
Drug: Ribavirin
Ribavirin tablets twice daily orally will be administered depending on body weight, according summary product characteristics and prescribing of ribavirin in real clinical practice.
Other Name: Copegus

  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
Participants with chronic hepatitis C and compensated liver cirrhosis (Class A by Child-Pugh scale) initiating treatment with Peginterferon alfa-2a and ribavirin
Criteria

Inclusion Criteria:

  • Serologically confirmed chronic hepatitis C (CHC), hepatitis C virus (HCV) RNA detectable
  • Compensated liver cirrhosis (Child-Pugh Class A) included
  • Initiating combined therapy with peginterferon alfa-2a and ribavirin

Exclusion Criteria:

  • Human immunodeficiency virus (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 57 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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: April 11, 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 20, 2017