Trial Outcomes & Findings for PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278) (NCT NCT00371761)
NCT ID: NCT00371761
Last Updated: 2017-04-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
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]
Results posted on
2017-04-06
Participant Flow
Participant milestones
| Measure |
PegIntron
PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
|
Adefovir
Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
Reasons for withdrawal
| Measure |
PegIntron
PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
|
Adefovir
Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Investigator Judgment
|
2
|
3
|
|
Overall Study
Study termination
|
4
|
3
|
Baseline Characteristics
PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)
Baseline characteristics by cohort
| Measure |
PegIntron
n=13 Participants
PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
|
Adefovir
n=12 Participants
Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
36.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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]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.
Outcome measures
| Measure |
PegIntron
n=13 Participants
PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
|
Adefovir
n=12 Participants
Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
|
|---|---|---|
|
Number of Participants With a Combined Response Consisting of All Three Responses - (a) Serological Response, (b) Virological Response, and (c) Biochemical Response
|
0 Participants
|
0 Participants
|
Adverse Events
PegIntron
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Adefovir
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PegIntron
n=13 participants at risk
|
Adefovir
n=12 participants at risk
|
|---|---|---|
|
Surgical and medical procedures
LAPAROSCOPIC SURGERY
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
Other adverse events
| Measure |
PegIntron
n=13 participants at risk
|
Adefovir
n=12 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
38.5%
5/13 • Number of events 9
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
15.4%
2/13 • Number of events 3
|
0.00%
0/12
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Ear and labyrinth disorders
VERTIGO
|
7.7%
1/13 • Number of events 2
|
0.00%
0/12
|
|
Eye disorders
CONJUNCTIVITIS
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/13
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
15.4%
2/13 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
15.4%
2/13 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
30.8%
4/13 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
REGURGITATION
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
VOMITING
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
General disorders
ASTHENIA
|
15.4%
2/13 • Number of events 3
|
0.00%
0/12
|
|
General disorders
CHEST PAIN
|
0.00%
0/13
|
8.3%
1/12 • Number of events 2
|
|
General disorders
CHILLS
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
General disorders
FATIGUE
|
15.4%
2/13 • Number of events 2
|
0.00%
0/12
|
|
General disorders
FEELING COLD
|
15.4%
2/13 • Number of events 3
|
0.00%
0/12
|
|
General disorders
FEELING HOT
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
General disorders
MALAISE
|
7.7%
1/13 • Number of events 12
|
0.00%
0/12
|
|
General disorders
PYREXIA
|
69.2%
9/13 • Number of events 63
|
0.00%
0/12
|
|
Immune system disorders
FOOD ALLERGY
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/13
|
8.3%
1/12 • Number of events 2
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.7%
1/13 • Number of events 1
|
16.7%
2/12 • Number of events 4
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
38.5%
5/13 • Number of events 6
|
8.3%
1/12 • Number of events 2
|
|
Investigations
ALPHA 1 FOETOPROTEIN INCREASED
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
23.1%
3/13 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
7.7%
1/13 • Number of events 4
|
0.00%
0/12
|
|
Investigations
HAEMOGLOBIN INCREASED
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Investigations
VITAMIN C INCREASED
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Investigations
WEIGHT DECREASED
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
ANOREXIA
|
15.4%
2/13 • Number of events 2
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
FASCIITIS
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TIGHTNESS
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
30.8%
4/13 • Number of events 4
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA OF LIVER
|
7.7%
1/13 • Number of events 2
|
0.00%
0/12
|
|
Nervous system disorders
HEADACHE
|
30.8%
4/13 • Number of events 26
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
SOMNOLENCE
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
23.1%
3/13 • Number of events 3
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
15.4%
2/13 • Number of events 2
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
RASH
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Surgical and medical procedures
DENTAL CARE
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER