MedTrace Logo

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

NCT01464008 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 297

Last updated 2016-09-27

No results posted yet for this study

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

Interventions

DRUG

Pegylated interferon alfa-2a and ribavirin

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. .

Sponsors & Collaborators

  • Beijing Ditan Hospital

    lead OTHER

Principal Investigators

  • Yao Xie, phD/MD · Beijing Ditan Hospital

Eligibility

Min Age
11 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2011-05-31
Completion
2011-09-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01464008 on ClinicalTrials.gov