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Completed

NCT Number: NCT01609049

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Altay Region Aids Center, Barnaul, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alfa-2a

Drug

Administration of treatment will be according to local recommendation under local labeling.

Other names: Pegasys

Ribavirin

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: STANDART

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 31, 2012
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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