NCT00380614

Brief Summary

Since a proportion of patients with Acute Viral Hepatitis-B develop severe hepatitis and fulminant hepatic failure, it is logical to believe that a rapid reduction in the HBV DNA levels by using antiviral agents could result in a less intense host response against the hepatitis B virus. However, the experience with lamivudine treatment of immunocompetent patients with AVH-B is limited.The aim of the present study was to evaluate the efficacy, utility and safety of lamivudine in treating immunocompetent patients with AVH-B.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed
Last Updated

September 26, 2006

Status Verified

September 1, 2006

First QC Date

September 25, 2006

Last Update Submit

September 25, 2006

Conditions

Hepatitis B

Keywords

Acute Hepatitis B, Lamivudine

Outcome Measures

Primary Outcomes (2)

  • clinical improvement

  • biochemical improvement

Interventions

LamivudineDRUG

Eligibility Criteria

Age5 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of acute hepatitis B
  • Bilirubin \> 5 mg/dl at presentation.

You may not qualify if:

  • Patients with co-infection, a history of hepatotoxic drug intake or alcohol use \>20g/day, or any evidence of chronic liver disease in the past, at presentation or during follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G.B. Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Shiv K Sarin, MD, DM

    G.B. Pant Hospital, New Delhi, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 26, 2006

Study Start

January 1, 2002

Study Completion

March 1, 2005

Last Updated

September 26, 2006

Record last verified: 2006-09

Locations

IN(1)