The Predictive Value of On-treatment Virological Response for Sustained Virological Response in Chronic Hepatitis C

NCT01464008 | Completed DMC

• 1 other identifier: DTH-XY001
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy of combination antiviral therapy for chronic hepatitis C is influenced by many factors. Important patient-specific factors include, age, gender, race, body weight. Important virus-specific factors include HCV genotype and serum HCV RNA level. Finally, important treatment-related factors include the type of interferon, dose of ribavirin and the duration and adherence to treatment. Despite the importance of patient- and virus-specific factors, the most important indicator of treatment success is a rapid, profound and sustained decrease in serum HCV RNA levels after the start of treatment. The on-treatment virological response can thus be used to predict the probability that a given patient will achieve an SVR if they remain on therapy. It can also be used to individualize the duration of treatment. In this study, treatment for patients with chronic hepatitis C was individualized on the basis of clinical characteristics and the on-treatment virological response. The aim was to investigate the usefulness of undetectable HCV RNA levels at week 4 (RVR) and 12 in tailoring the duration of treatment and predicting SVR in Chinese patients with chronic hepatitis C.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Sustained virus response

  after treatment, the HCV RNA levels were tested before treatment, at week 4, 12, and 24, and at the end of treatment, and 24 weeks after completion of treatment. The sustained virus response was defined as HCV RNA undetectabale at 24 week after completion of treatment.

  serum HCV RNA was undetectabale at the end of treatment and 24 weeks follow

Study Arms (1)

chronic hepatitis C

Drug: Pegylated interferon alfa-2a and ribavirin

Interventions

Pegylated interferon alfa-2a and ribavirin DRUG

all patients were given peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland) 135 or 180 µg by subcutaneous injection once weekly, and received twice daily oral ribavirin at a target total daily dose of 13 mg/kg/day. .

Also known as: Pegasys®; Roche, Basel, Switzerland

chronic hepatitis C

Eligibility Criteria

• Age: 11 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with chronic hepatitis C who were admitted to hospital or treated as outpatients at Beijing Ditan Hospital were eligible for the study.

You may qualify if:

• Patients with anti-HCV and HCV RNA positive for at least 6 months

You may not qualify if:

• Had a haemoglobin level \<100 g/L
• Neutrophil count \<1.5 x 109/L
• Platelet count \<50 x 109/L
• Decompensated liver cirrhosis or liver disease other than that attributable to chronic hepatitis C
• Co-infected with hepatitis B virus or human immunodeficiency virus
• Had an autoimmune disease, liver tumour, or severe cardiac disease.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Beijing Ditan hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Yao Xie, phD/MD

  Beijing Ditan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver diseases center

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 2, 2011
• Study Start: January 1, 2004
• Primary Completion: May 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

CN (1)