Trial Outcomes & Findings for Tenofovir Alone Versus Tenofovir With Emtricitabine to Treat Chronic Hepatitis B (NCT NCT00524173)

Results Overview

Number of subjects whose serum HBV DNA level was \<1000 IU/ml at Week 48

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

At Week 48

Results posted on

2019-06-05

Participant Flow

The enrollment number in the Protocol Section (35) conflicts with the number of participants Started in the Participant Flow module (32). Two participants failed screening and one participant declined participation after enrollment and prior to beginning treatment.

Participant milestones

Participant milestones
Measure	Tenofovir Only Tenofovir 300mg by mouth daily for 192 weeks Tenofovir	Tenofovir & Emtricitabine Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks Tenofovir \& Emtricitabine
Overall Study STARTED	17	15
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Tenofovir Only Tenofovir 300mg by mouth daily for 192 weeks Tenofovir	Tenofovir & Emtricitabine Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks Tenofovir \& Emtricitabine
Overall Study Lost to Follow-up	0	1
Overall Study Death	1	0
Overall Study Had not reached endpoint at study close	4	1

Baseline Characteristics

Tenofovir Alone Versus Tenofovir With Emtricitabine to Treat Chronic Hepatitis B

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tenofovir Only n=17 Participants Tenofovir 300mg by mouth daily for 192 weeks Tenofovir	Tenofovir & Emtricitabine n=15 Participants Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks Tenofovir \& Emtricitabine	Total n=32 Participants Total of all reporting groups
Age, Continuous	39.65 years STANDARD_DEVIATION 16.66 • n=5 Participants	39.47 years STANDARD_DEVIATION 12.67 • n=7 Participants	39.56 years STANDARD_DEVIATION 14.69 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Asian	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 48

Population: The number of participants analyzed (25) is smaller than the number of participants started (32). One participant was lost to follow-up prior to the endpoint, one died prior to the endpoint, and 5 had not reached the endpoint at study closure. Patients were transferred to another protocol to continue treatment as appropriate.

Number of subjects whose serum HBV DNA level was \<1000 IU/ml at Week 48

Outcome measures

Outcome measures
Measure	Tenofovir Only n=12 Participants Tenofovir 300mg by mouth daily for 192 weeks Tenofovir	Tenofovir & Emtricitabine n=13 Participants Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks Tenofovir \& Emtricitabine
Number of Subjects With Hepatitis b Virus (HBV) DNA <1000 IU/ml at Week 48	11 Participants	13 Participants

PRIMARY outcome

Timeframe: At Week 192

Population: The number of participants analyzed (25) is smaller than the number of participants started (32). One participant was lost to follow-up prior to the endpoint, one died prior to the endpoint, and 5 had not reached the endpoint at study closure. Patients were transferred to another protocol to continue treatment as appropriate.

Number of participants whose serum HBV DNA level was \<1000 IU/ml at Week 192

Outcome measures

Outcome measures
Measure	Tenofovir Only n=12 Participants Tenofovir 300mg by mouth daily for 192 weeks Tenofovir	Tenofovir & Emtricitabine n=13 Participants Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks Tenofovir \& Emtricitabine
Number of Participants With HBV DNA <1000 IU/ml at Week 192	12 Participants	12 Participants

SECONDARY outcome

Timeframe: 192 weeks

Population: The number of participants analyzed (25) is smaller than the number of participants started (32). One participant was lost to follow-up prior to the endpoint, one died prior to the endpoint, and 5 had not reached the endpoint at study closure. Patients were transferred to another protocol to continue treatment as appropriate.

Number of participants whose serum ALT levels were measured within normal limits.

Outcome measures

Outcome measures
Measure	Tenofovir Only n=12 Participants Tenofovir 300mg by mouth daily for 192 weeks Tenofovir	Tenofovir & Emtricitabine n=13 Participants Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks Tenofovir \& Emtricitabine
Number of Participants With Normalized Alanine Aminotransferase (ALT)	8 Participants	13 Participants

SECONDARY outcome

Timeframe: 192 weeks

Population: The number of participants analyzed (25) is smaller than the number of participants started (32). One participant was lost to follow-up prior to the endpoint, one died prior to the endpoint, and 5 had not reached the endpoint at study closure. Patients were transferred to another protocol to continue treatment as appropriate.

The number of participants whose serum hepatitis B surface antigen was no longer detectable.

Outcome measures

Outcome measures
Measure	Tenofovir Only n=12 Participants Tenofovir 300mg by mouth daily for 192 weeks Tenofovir	Tenofovir & Emtricitabine n=13 Participants Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks Tenofovir \& Emtricitabine
Number of Participants With Loss of HBsAg	1 Participants	0 Participants

Adverse Events

Tenofovir Only

Serious events: 1 serious events

Other events: 7 other events

Deaths: 1 deaths

Tenofovir & Emtricitabine

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tenofovir Only n=17 participants at risk Tenofovir 300mg by mouth daily for 192 weeks Tenofovir	Tenofovir & Emtricitabine n=15 participants at risk Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks Tenofovir \& Emtricitabine
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	5.9% 1/17 • Number of events 1 • 192 weeks	0.00% 0/15 • 192 weeks

Other adverse events

Other adverse events
Measure	Tenofovir Only n=17 participants at risk Tenofovir 300mg by mouth daily for 192 weeks Tenofovir	Tenofovir & Emtricitabine n=15 participants at risk Tenofovir 300mg in combination with emtricitabine 200mg by mouth daily for 192 weeks Tenofovir \& Emtricitabine
Hepatobiliary disorders Aalanine aminotransferase >5xULN	11.8% 2/17 • 192 weeks	20.0% 3/15 • 192 weeks
Hepatobiliary disorders Aspartate Aminotransferase > 5xULN	5.9% 1/17 • 192 weeks	20.0% 3/15 • 192 weeks
Musculoskeletal and connective tissue disorders Creatine kinase > 4xULN	17.6% 3/17 • 192 weeks	20.0% 3/15 • 192 weeks
Blood and lymphatic system disorders Neutrophils (<750mm^3)	5.9% 1/17 • 192 weeks	0.00% 0/15 • 192 weeks
Endocrine disorders Serum amylase >2xULN	0.00% 0/17 • 192 weeks	6.7% 1/15 • 192 weeks

Additional Information

Marc Ghany, MD

NIDDK

Phone: 301-402-5115

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place