EFFORT Further Extension Study

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: Telbivudine; Other: off-treatment follow-up; Drug: Adefovir dipivoxil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02826070

MOH-09

Details and patient eligibility

About

The purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fibrosis/cirrhosis.

Enrollment: 130 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who completed EFFORT extension study.
2. Patients who had baseline (that is the week 0 of EFFORT study) HBV DNA <9 Log copies/mL and ALT ≥2×ULN.
3. Patients who are willing to participate in the further extension study.
4. Patient is willing and able to comply with the study drug regimen and all other study requirements.
5. Patients must give written informed consent before any assessment is performed.

Exclusion criteria

1. Poor compliance judged by investigators

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Off-treatment

Other group

Description:

Patients who had stopped treatment during EFFORT extension study could receive 2-year off-treatment follow-up. All the patients in Part I will be followed up at the interval of 12 weeks. For these patients, if they have hepatitis flare during follow-up, they will be re-treated with telbivudine combined with adefovir for the left study period ( the total study period is 2 years) and followed up at the interval of 12 weeks. Hepatitis flare is defined as HBV DNA\>4 Log10 copies/mL with either ALT≥5 times upper limit of normal (ULN) or TBIL≥2×ULN，or 2 ≤ALT ≤5 ×ULN (at two consecutive visits at least 2 weeks apart) and total bilirubin (TBIL) \<2×ULN.

Treatment:

Other: off-treatment follow-up

On-treatment

Other group

Description:

Patients with continuous treatment during EFFORT extension study will continue treatment, without off-treatment rule in the further extension study. The treatment strategy is depended on the HBV DNA level of each individual, that is, for patients with negative HBV DNA level (defined as HBV DNA \<20 IU/mL) will continue their previous treatment strategy; and for patients with positive HBV DNA level (defined as HBV DNA\>=20 IU/mL) will receive the combination therapy of telbivudine and adefovir, irrespective of their previous treatment strategy. All the patients in Part II will be followed up at the interval of 24 weeks until they complete the 2-year on-treatment follow-up. Patients will be conducted liver biopsy at the sixth year of treatment. All the patients with telbivudine monotherapy will be switched to telbivudine plus adefovir once confirmed HBV DNA breakthrough developed.

Treatment:

Drug: Adefovir dipivoxil

Drug: Telbivudine