Trial Outcomes & Findings for Study of Telbivudine in Chronic Hepatitis B (NCT NCT00970216)

Last Updated: 2016-02-29

Results Overview

Recruitment status

COMPLETED

Target enrollment

160 participants

Primary outcome timeframe

48 weeks

Results posted on

2016-02-29

Participant milestones
Measure	Chronic Hepatitis B Patients with chronic hepatitis B, who received Telbivudine treatment
Overall Study STARTED	160
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	80

Withdrawal data not reported

Study of Telbivudine in Chronic Hepatitis B

Baseline characteristics by cohort
Measure	Chronic Hepatitis B n=160 Participants Patients with chronic hepatitis B, who received Telbivudine treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	150 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	52.9 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	131 Participants n=5 Participants
Region of Enrollment Taiwan	160 participants n=5 Participants

Timeframe: 48 weeks

Outcome measures
Measure	Chronic Hepatitis B n=160 Participants Patients with chronic hepatitis B, who received Telbivudine treatment
HBV-DNA < 300 Copies/mL in 48 Weeks	79 participants

Serious events: 0 serious events

Other events: 78 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Chronic Hepatitis B n=160 participants at risk Patients with chronic hepatitis B, who received Telbivudine treatment
General disorders Fever, mild	3.1% 5/160 • Number of events 5
Musculoskeletal and connective tissue disorders Muscle skeleton discomfort	11.2% 18/160 • Number of events 29
Skin and subcutaneous tissue disorders Skin rash and itching	3.1% 5/160 • Number of events 6
Nervous system disorders Dizziness and headache	7.5% 12/160 • Number of events 26
Gastrointestinal disorders Abdominal discomfort	11.9% 19/160 • Number of events 45
Respiratory, thoracic and mediastinal disorders Cough	3.8% 6/160 • Number of events 6
Cardiac disorders Palpitation	0.62% 1/160 • Number of events 1
General disorders Fatigue	7.5% 12/160 • Number of events 12

Chang Gung Memorial Hospital

Phone: 88633281200