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NCT00410202 · ClinicalTrials.gov registry record · Phase 3

Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus

A Phase 3 study of Hepatitis B， Chronic, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
629
Enrollment target
20
Study locations

NCT00410202: Completed Phase 3 study of Hepatitis B， Chronic, sponsored by Bristol-Myers Squibb.

NCT00410202 is a Phase 3 study of Hepatitis B， Chronic that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 629 participants, above the 501-participant average among 6 other Hepatitis B， Chronic trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00410202, a Phase 3 study of Hepatitis B， Chronic, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
629 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine

Primary Outcome

HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. HBV DNA less than (\<)50 International units per milliliter (IU/mL) = approximately 300 copies/mL. Percentage of participants calculated n/N; n= number of participants with HBV DNA \<50 IU/mL; N = number of participants analyzed.

Conditions Studied

Hepatitis B， Chronic

Interventions

  • DRUG Lamivudine
  • DRUG Tenofovir
  • DRUG Entecavir
  • DRUG Adefovir

Study Locations (20)

Other

  • Local Institution - Athens
  • Local Institution - Tai Po
  • Local Institution - Ahmedabad
  • Local Institution - Chandigarh
  • Local Institution - Indore
  • Local Institution - Ludhiana
  • Local Institution - New Delhi
  • Local Institution - Vellore
  • Local Institution - Jakarta
  • Local Institution - Antella, Firenze
  • Local Institution - Kuala Lumpur

New South Wales

  • Local Institution - Concord
  • Local Institution - Randwick

Connecticut

  • University Of Connecticut Health Center - Farmington

Rio Grande do Sul

  • Local Institution - Porto Alegre Rs

Alberta

  • Local Institution - Calgary

Hong Kong

  • Local Institution - Hong Kong

New Territories

  • Local Institution - Shatin

Uttar Pradesh

  • Local Institution - Lucknow

Trial Details

FieldValue
Enrollment Target 629 participants
Start Date 2008-03
Est. Completion 2012-07
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the finished NCT00410202 record still lists

NCT00410202 is an interventional study that assigns participants to a tested intervention. The registered 629 participants enrollment target is mid-sized for trials with a published cap, above the 501-participant average among 6 other Hepatitis B， Chronic trials with a reported enrollment target (26% higher).

The record links to 1 condition, with Hepatitis B， Chronic appearing as the primary indexed condition, and to 4 interventions - of which Lamivudine is the first listed.

NCT00410202 names 20 study sites across 9 states, led by Other, New South Wales, Connecticut.

Frequently Asked Questions

What is clinical trial NCT00410202 about?

NCT00410202 is a clinical study titled "Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus". The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine

What is the current status of trial NCT00410202?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 629 participants. The study started on 2008-03. Estimated completion is 2012-07.

What conditions does trial NCT00410202 study?

This clinical trial studies the following conditions: Hepatitis B， Chronic.

What interventions are being tested in trial NCT00410202?

The interventions under investigation include: Lamivudine (DRUG), Tenofovir (DRUG), Entecavir (DRUG), Adefovir (DRUG).

Who is sponsoring clinical trial NCT00410202?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00410202 being conducted?

This trial has 20 study locations across Connecticut, New South Wales, Rio Grande do Sul, Alberta, Hong Kong. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT00410202, the US trial registry maintained by the National Library of Medicine. NCT00410202 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.