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A Randomized Controlled Trial of Lamivudine in Acute Hepatitis B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00380614
Recruitment Status : Completed
First Posted : September 26, 2006
Last Update Posted : September 26, 2006
Sponsor:
Information provided by:
Maulana Azad Medical College

Tracking Information
First Submitted Date  ICMJE September 25, 2006
First Posted Date  ICMJE September 26, 2006
Last Update Posted Date September 26, 2006
Study Start Date  ICMJE January 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September¬†25,¬†2006)
  • clinical improvement
  • biochemical improvement
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial of Lamivudine in Acute Hepatitis B
Official Title  ICMJE Not Provided
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.
Detailed Description

The diagnosis of acute hepatitis B was based on recent onset acute illness including prodromal symptoms, jaundice and other typical symptoms. The laboratory investigations supporting the diagnosis of acute hepatitis included the presence of >2.5 times the upper limit of serum alanine aminotransferase (ALT) and serum bilirubin, and positive IgM anti-HBc test. Ultrasound, and esophagogastroduodenoscopy was done to look for any evidence of chronic liver disease. All patients had normal alpha-fetoprotein levels.

Co-infection with hepatitis A, C, D, E and human immunodeficiency virus (HIV) infection was looked for by appropriate serologic tests conducted within 7 days of presentation.

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 were excluded. Patients were also excluded if they had serum bilirubin < 5 mg/dl at presentation.

Patients were classified as severe AVH-B if they fulfilled any two of the following criteria: (1) hepatic encephalopathy; (2) serum bilirubin ≥10.0 mg/dl; and (3) international normalized ratio (INR) ≥1.6.

The patients were randomized into 2 groups: Group 1: Treatment with lamivudine 100 mg daily for 3 months, Group 2: Placebo. Randomization was done using random number table. The initial study and randomization was planned to enroll 120 patients or continue the study till three years, whichever was earlier. Individual rather than block randomization was done The investigators as well as the patients were blinded to the randomisation. The patients in the placebo group received a placebo pill.

All patients were monitored during treatment for clinical evidence and grade of hepatic encephalopathy, impaired coagulation (abnormal international normalized ratio, IINR), AST/ALT, serum albumin bilirubin levels every week for the first month and then monthly. HBV serology, including serum HBsAg, HBeAg, and anti-HBe were checked at baseline and every 3 months. Anti-HBs titres were checked at 6 and 12 months. Quantitative HBV DNA assay was performed on day 0, day 4, week 1, week 2, week 3, week 4, then every month for the next 2 months and then every 3 months for 12 months.

All patients were followed for at least 12 months after the onset of AVH-B. Development of protective anti-HBs(>10 IU/L) was specifically looked for.

Exacerbation of chronic hepatitis B was excluded by investigating thoroughly for any evidence of chronic liver disease by Ultrasound, Upper GI endoscopy, or low albumin at presentation. Ultrasound was repeated at 6 and 12 months, and if there was any suspicion Upper GI endoscopy was also repeated. LFTS were done at every hospital visit.

HBsAg, HBeAg, IgM anti-HBc, anti-HBs, and anti-HBe were tested by commercially available enzyme-linked immunoassays. Serum quantitative HBV DNA assay was performed by use of an ultra sensitive Hybrid capture assay [Digene Labs, USA] that has a lower limit of detection of 4,700 copies/ml. An arbitrary value of 4,700 copies/ml was assigned to values < 4,700 copies/ml for analysis purposes. In such patients HBV DNA was done by an in-house qualitative PCR test to indicate negativity or positivity of viral DNA. The lower limit of detection was 600 copies/ml.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B
Intervention  ICMJE Drug: Lamivudine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00380614
Other Study ID Numbers  ICMJE Ethical/Path/GBPH/805
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Maulana Azad Medical College
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shiv K Sarin, MD, DM G.B. Pant Hospital, New Delhi, India
PRS Account Maulana Azad Medical College
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP