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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)

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ClinicalTrials.gov Identifier: NCT01609049
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment
Hepatitis C, Chronic Drug: Peginterferon alfa-2a Drug: Ribavirin

Study Type : Observational
Actual Enrollment : 1496 participants
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
Actual Study Start Date : December 7, 2011
Primary Completion Date : June 22, 2015
Study Completion Date : June 22, 2015

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 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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Percentage of Previously Treated Participants With SVR and Negative HCV RNA (< 50 IU/mL) at Week 12 [ Time Frame: Week 12 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Percentage of Naive Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24 [ Time Frame: Week 24 ]
  7. 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 ]
  8. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 3.5 years ]

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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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609049

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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01609049     History of Changes
Other Study ID Numbers: ML27851
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs