Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02338674
Other study ID # HBV-AR
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 2014
Est. completion date October 2017

Study information

Verified date September 2018
Source Fuzhou General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. However, no consensus is reached regarding the antiviral therapy in this group. This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date October 2017
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- aged 18-45 years old with artificial reproductive needs

- Liver function (ALT) <40U/L for male and <30 for female

- HBV-DNA> 10e+5

- HBVeAg +

- History> 0.5 years

Exclusion Criteria:

- Cirrhosis

- Combined with other liver diseases such as autoimmune liver disease, alcoholic liver disease, fatty liver

- Liver or other parts of malignancies

- Bilirubin> 17.1

- GGT> 2ULN

- Liver transplant patients

- combined HCV, HDV, HIV infection

- A history of anti-HBV drug resistance

- History of habitual abortion

- previous fetal malformation history

- CRP> 3.0ng / ml

- Uncontrolled hypertension

- Proteinuria or Calculated creatinine clearance < 70 mL/min

- Heart failure or acute coronary syndrome

- Coagulopathy

- Drug or alcohol addiction

- Hyperlipidemia LDL> 4.6 or TG> 2.0

- Alphafetoprotein > 50 ng/mL

- Received interferon (pegylated or not) therapy within 6 months of the screening visit

- Evidence of hepatocellular carcinoma

- Received solid organ or bone marrow transplantation

- Was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents

- Known hypersensitivity to the study drugs, the metabolites, or formulation excipients

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tenofovir and telbivudine
tenofovir and telbivudine administered at least 48 weeks
Tenofovir
tenofovir administered at least 48 weeks

Locations

Country Name City State
China Fuzhou General Hospital, Xiamen Univ Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12 week 12
Secondary Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48 Week 24, 36 and 48
Secondary Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48 Week 12, 24, 36 and 48
Secondary Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48 Week 12, 24, 36 and 48
Secondary Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48 Week 12, 24, 36 and 48
Secondary Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48 Week 12, 24, 36 and 48
Secondary Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48 Week 12, 24, 36 and 48
Secondary Occurrence of HBV Resistance Mutations Baseline to Week 48
Secondary off-treatment recurrence of HBV Week 72 to 96
Secondary Down syndrome Occurrence week 13 of pregnancy
Secondary Fetal Malformations Occurrence week 26 of pregnancy
See also
  Status Clinical Trial Phase
Completed NCT03272009 - Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects Phase 1
Recruiting NCT01456312 - HBsAg Related Response Guided Therapy Phase 4
Terminated NCT01886300 - An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam N/A
Completed NCT00962975 - A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies Phase 1
Completed NCT01023230 - A Study to Assess DV-601 in Subjects With Chronic Hepatitis B Phase 1
Terminated NCT00460850 - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B. Phase 4
Completed NCT00536263 - PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327) Phase 3
Completed NCT03681132 - The Norwegian Nucleoside Analogue Stop Study Phase 4
Active, not recruiting NCT05473806 - Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes Phase 4
Withdrawn NCT01179594 - A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B. Phase 4
Recruiting NCT05057065 - A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
Completed NCT04439539 - A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection Phase 2
Withdrawn NCT03125213 - A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects Phase 2
Active, not recruiting NCT04782375 - Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B Phase 4
Withdrawn NCT05550519 - A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment Early Phase 1
Completed NCT02693652 - A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine Phase 1/Phase 2
Enrolling by invitation NCT04160897 - Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
Active, not recruiting NCT02588937 - Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients Phase 4
Completed NCT02612506 - Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers Phase 1
Recruiting NCT02327416 - A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study) Phase 3