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PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)

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ClinicalTrials.gov Identifier: NCT00371761
Recruitment Status : Completed
First Posted : September 4, 2006
Results First Posted : December 15, 2010
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis B, Chronic (CHB)
Interventions Biological: Pegylated interferon alfa-2b (PegIntron)
Drug: Adefovir dipivoxil (adefovir)
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PegIntron Adefovir
Hide Arm/Group Description PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
Period Title: Overall Study
Started 13 12
Completed 5 2
Not Completed 8 10
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             1             3
Investigator Judgment             2             3
Study termination             4             3
Arm/Group Title PegIntron Adefovir Total
Hide Arm/Group Description PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase Total of all reporting groups
Overall Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants
36.7  (8.5) 36.7  (13.6) 36.7  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
4
  30.8%
1
   8.3%
5
  20.0%
Male
9
  69.2%
11
  91.7%
20
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan, Province Of China Number Analyzed 13 participants 12 participants 25 participants
13 12 25
1.Primary Outcome
Title Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response
Hide Description
  1. Serological response is defined as Loss of HBeAg (Hepatitis B e antigen) and Appearance of anti-HBe (Hepatitis B e antibodies); participant is HBeAg negative and anti-HBe positive.
  2. Virological response was defined as having < 10^5 copies/mL of serum HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) by real-time PCR (Polymerase Chain Reaction).
  3. Biochemical response was defined as acheiving normal levels of ALT (Alanine Aminotransferase) level in Units/L.
Time Frame At Week 72 [for Pegylated interferon alfa-2b (PegIntron), at 48 weeks post PegIntron treatment for up to 24 weeks; for Adefovir, at 24 weeks post adefovir treatment for up to 48 weeks]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PegIntron Adefovir
Hide Arm/Group Description:
PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
Overall Number of Participants Analyzed 13 12
Measure Type: Number
Unit of Measure: Participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PegIntron Adefovir
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
PegIntron Adefovir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PegIntron Adefovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      0/12 (0.00%)    
Surgical and medical procedures     
LAPAROSCOPIC SURGERY  1  1/13 (7.69%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PegIntron Adefovir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/13 (100.00%)      8/12 (66.67%)    
Blood and lymphatic system disorders     
LEUKOPENIA  1  5/13 (38.46%)  9 0/12 (0.00%)  0
THROMBOCYTOPENIA  1  2/13 (15.38%)  3 0/12 (0.00%)  0
Cardiac disorders     
PALPITATIONS  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Ear and labyrinth disorders     
VERTIGO  1  1/13 (7.69%)  2 0/12 (0.00%)  0
Eye disorders     
CONJUNCTIVITIS  1  1/13 (7.69%)  1 0/12 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  0/13 (0.00%)  0 2/12 (16.67%)  2
ABDOMINAL PAIN UPPER  1  2/13 (15.38%)  2 1/12 (8.33%)  1
DIARRHOEA  1  2/13 (15.38%)  2 1/12 (8.33%)  1
NAUSEA  1  4/13 (30.77%)  4 1/12 (8.33%)  1
REGURGITATION  1  1/13 (7.69%)  1 0/12 (0.00%)  0
VOMITING  1  1/13 (7.69%)  1 0/12 (0.00%)  0
General disorders     
ASTHENIA  1  2/13 (15.38%)  3 0/12 (0.00%)  0
CHEST PAIN  1  0/13 (0.00%)  0 1/12 (8.33%)  2
CHILLS  1  1/13 (7.69%)  1 0/12 (0.00%)  0
FATIGUE  1  2/13 (15.38%)  2 0/12 (0.00%)  0
FEELING COLD  1  2/13 (15.38%)  3 0/12 (0.00%)  0
FEELING HOT  1  1/13 (7.69%)  1 0/12 (0.00%)  0
MALAISE  1  1/13 (7.69%)  12 0/12 (0.00%)  0
PYREXIA  1  9/13 (69.23%)  63 0/12 (0.00%)  0
Immune system disorders     
FOOD ALLERGY  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations     
NASOPHARYNGITIS  1  0/13 (0.00%)  0 1/12 (8.33%)  2
UPPER RESPIRATORY TRACT INFECTION  1  1/13 (7.69%)  1 2/12 (16.67%)  4
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  5/13 (38.46%)  6 1/12 (8.33%)  2
ALPHA 1 FOETOPROTEIN INCREASED  1  1/13 (7.69%)  1 0/12 (0.00%)  0
ASPARTATE AMINOTRANSFERASE INCREASED  1  3/13 (23.08%)  4 1/12 (8.33%)  1
BLOOD BILIRUBIN INCREASED  1  1/13 (7.69%)  4 0/12 (0.00%)  0
HAEMOGLOBIN INCREASED  1  0/13 (0.00%)  0 1/12 (8.33%)  1
LIVER FUNCTION TEST ABNORMAL  1  0/13 (0.00%)  0 1/12 (8.33%)  1
VITAMIN C INCREASED  1  1/13 (7.69%)  1 0/12 (0.00%)  0
WEIGHT DECREASED  1  1/13 (7.69%)  1 0/12 (0.00%)  0
Metabolism and nutrition disorders     
ANOREXIA  1  2/13 (15.38%)  2 0/12 (0.00%)  0
DECREASED APPETITE  1  1/13 (7.69%)  1 0/12 (0.00%)  0
HYPERURICAEMIA  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  1/13 (7.69%)  1 0/12 (0.00%)  0
BACK PAIN  1  0/13 (0.00%)  0 1/12 (8.33%)  1
FASCIITIS  1  1/13 (7.69%)  1 0/12 (0.00%)  0
MUSCLE TIGHTNESS  1  1/13 (7.69%)  1 0/12 (0.00%)  0
MYALGIA  1  4/13 (30.77%)  4 0/12 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
HAEMANGIOMA OF LIVER  1  1/13 (7.69%)  2 0/12 (0.00%)  0
Nervous system disorders     
HEADACHE  1  4/13 (30.77%)  26 1/12 (8.33%)  1
SOMNOLENCE  1  1/13 (7.69%)  1 0/12 (0.00%)  0
Psychiatric disorders     
INSOMNIA  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Reproductive system and breast disorders     
OVARIAN CYST  1  1/13 (7.69%)  1 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
COUGH  1  1/13 (7.69%)  1 0/12 (0.00%)  0
RHINITIS ALLERGIC  1  1/13 (7.69%)  1 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders     
ALOPECIA  1  3/13 (23.08%)  3 0/12 (0.00%)  0
ECZEMA  1  2/13 (15.38%)  2 0/12 (0.00%)  0
PRURITUS  1  1/13 (7.69%)  1 0/12 (0.00%)  0
RASH  1  1/13 (7.69%)  1 0/12 (0.00%)  0
Surgical and medical procedures     
DENTAL CARE  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal Investigator and Institution agree not to publish or publicly present any interim results of the study. Principal Investigator and Institution further agree to provide 45 days written notice to Sponsor prior to submission for publication or presentation to permit Sponsor to review drafts of abstracts and manuscripts for publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00371761     History of Changes
Other Study ID Numbers: P04498
First Submitted: August 31, 2006
First Posted: September 4, 2006
Results First Submitted: July 15, 2010
Results First Posted: December 15, 2010
Last Update Posted: April 6, 2017