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

April 11, 2017 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1496

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 46033
        • Dongnam Inst.of Radiological & Medical Sciences
  • Russian Federation
      • Barnaul, Russian Federation, 656010
        • Altay Region Aids Center
      • Barnaul, Russian Federation, 656045
        • Barnaul City Hospital #5; Therapy
      • Chelyabinsk, Russian Federation, 454052
        • Chelyabinsk State Medical Academy; Infectious Diseases
      • Chita, Russian Federation, 672090
        • Chita State Medical Academy
      • Ekaterinburg, Russian Federation, 620102
        • Ekaterinburg Regional Hospital #1; Gastroenterology
      • Irkutsk, Russian Federation, 664047
        • Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
      • Kaluga, Russian Federation, 248023
        • Kaluga regional AIDS center
      • Kazan, Russian Federation, 420012
        • Kazan State Medical University
      • Kemerovo, Russian Federation, 650036
        • Kemerovo City Infectious Clinical Hospital; Infectious
      • Khabarovsk, Russian Federation, 680022
        • Khabarovsk-1 Road Clinical Hospital; Gastroenterology
      • Khabarovsk, Russian Federation, 680031
        • Aids Center; Infectious
      • Kirov, Russian Federation, 610000
        • Kirov Region Aids-Center; Infectious
      • Krasnodar, Russian Federation, 350015
        • Clinical Center for the Prevention and Control of AIDS and Infectious Diseases
      • Krasnodar, Russian Federation, 350015
        • Specialized clinical infectious hospital
      • Krasnoyarsk, Russian Federation, 660022
        • Region Cinical Hospital; Gastroenterology
      • Krasnoyarsk, Russian Federation, 660049
        • Krasnoyarsk Region Aids Center; Hepatology
      • Lipetsk, Russian Federation, 398043
        • Lipetsk Region Aids Center
      • Moscow, Russian Federation, 111123
        • The scientific-research institute of epidemiology
      • Moscow, Russian Federation, 115201
        • Central Medicosanitary Dept #165
      • Moscow, Russian Federation, 117292
        • Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases
      • Moscow, Russian Federation, 117333
        • Central Clinical Hospital of RAS ; HEPATOLOGY
      • Moscow, Russian Federation, 119002
        • FGBU "Polyclinic #1 Administration President RF
      • Moscow, Russian Federation, 119881
        • I.M. Sechenov First Moscow State Medical University, The V.H.Vasilenko Clinic
      • Moscow, Russian Federation, 119992
        • I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic
      • Moscow, Russian Federation, 123367
        • Hosital of Infectious Disease #1
      • Moscow, Russian Federation, 123367
        • State Medical Stomatological Uni ; Infectious
      • Moscow, Russian Federation, 125101
        • Russian Medical Academy of Postgraduate Education on Botkin S.P. ; City Clinical Hospital
      • Moscow, Russian Federation, 127009
        • City Hospital # 24; Hepatology
      • Moscow, Russian Federation, 129110
        • Clinical hospital Centrosouz
      • Moscow, Russian Federation, 143420
        • 3-D Military Clinical Hospital
      • Moscow, Russian Federation
        • Medelitconsulting; Medical
      • Nizniy Novgorod, Russian Federation, 603005
        • AIDS Center
      • Novosibirsk, Russian Federation, 630016
        • Infections Deseases Hospital #1
      • Petrozavodsk, Russian Federation, 185019
        • Baranov Republican Hospital
      • Rostov-na-donu, Russian Federation, 344010
        • City Hospital #1 After Semashko N.A.
      • Rostov-na-donu, Russian Federation, 344022
        • Rostov State Medical Uni ; Infectious Diseases
      • Rostov-na-donu, Russian Federation, 344029
        • City Hospital #2; Nefrology
      • Ryazan, Russian Federation, 390011
        • Ryazan State Medical University named after I.P.Pavlov
      • Saint-Petersburg, Russian Federation, 195030
        • City polyclinic №107
      • Saint-Petersburg, Russian Federation, 197376
        • Research institute of influenza named after I.I.Mechnikov
      • Samara, Russian Federation, 443100
        • MC Gepatolog
      • Samara, Russian Federation, 443021
        • Samara State Medical Uni ; Hepatogastroenterology
      • Saratov, Russian Federation, 410028
        • City Clinical Hospital №2; Infectional diseases department
      • Saratov, Russian Federation, 410040
        • Saratov Region Aids Center; Infectious Diseases
      • St Petersburg, Russian Federation, 194044
        • Military Medical Academy; Infectious Deseases
      • St Petersburg, Russian Federation, 198103
        • St. Petersburg Aids Center; Haepatology
      • St. Petersburg, Russian Federation, 191167
        • S.P. Botkin Clinical Infectious Disease Hospital
      • Stavropol, Russian Federation, 355017
        • Stavropol State Medical Academy
      • Tumen, Russian Federation, 625026
        • Consulting diagnostic center
      • UFA, Russian Federation, 450000
        • State Medical Uni of Republic Bashkortostan; Infection Diseases
      • Vladivostok, Russian Federation, 690002
        • Vladivostok State Medical University
      • Vladivostok, Russian Federation, 690065
        • MUZ City Clinical Infectional Hospital
      • Volgograd, Russian Federation, 400040
        • Volgograd Regional Aids Center For Aids and Infectious Diseases T Volgograd
      • Voronezh, Russian Federation, 394030
        • Regional Clinical Hospital of Infectious Diseases
      • Yakutsk, Russian Federation, 677019
        • Yakutsk City Hospital
      • Yoshkar-Ola, Russian Federation, 424037
        • National Center for Prevention and Control of AIDS and Infectious Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline up to 24 Weeks Post Therapy Completion (approximately 3.5 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Week 4, 12
Percentage of Previously Treated Participants With SVR and Negative HCV RNA (< 50 IU/mL) at Week 12
Time Frame: Week 12
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
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
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
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
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
Baseline up to approximately 3.5 years
Percentage of Participants With Adverse Events
Time Frame: Baseline up to approximately 3.5 years
Baseline up to approximately 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2011

Primary Completion (Actual)

June 22, 2015

Study Completion (Actual)

June 22, 2015

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (Estimate)

May 31, 2012

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML27851

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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