Tenofovir in Chronic Hepatitis B With Mild ALT Elevation
This study is currently recruiting participants.
Verified October 2012 by E-DA Hospital
Sponsor:
E-DA Hospital
Collaborators:
Gilead Sciences
Taipei Institute of Pathology, Taiwan
Information provided by (Responsible Party):
Hung Chi Chen, E-DA Hospital
ClinicalTrials.gov Identifier:
NCT01522625
First received: January 27, 2012
Last updated: October 14, 2012
Last verified: October 2012
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Purpose
This study aims to clarify whether patients with chronic hepatitis B with high viral load will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B |
Drug: tenofovir disoproxil fumarate 300mg per day Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Efficacy of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients With High Viral Load But Slight Aminotransferase Elevation |
Resource links provided by NLM:
Drug Information available for:
Formic acid
Tenofovir
Tenofovir Disoproxil Fumarate
Recombinant Hepatitis B vaccine
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by E-DA Hospital:
Primary Outcome Measures:
- Severity of hepatic necroinflammation and fibrosis [ Time Frame: Within one month after completion of antiviral therapy ] [ Designated as safety issue: No ]Primary outcome is the severity of necroinflammation and fibrosis in liver tissue as evaluated by Knodell and Ishak scoring system
Secondary Outcome Measures:
- Undetectable hepatitis B viral DNA [ Time Frame: Within one month after completion of antiviral therapy ] [ Designated as safety issue: No ]HBV DNA viral DNA not detected in serum
- Normalization of serum alanine aminotransferase [ Time Frame: Within one month after completion of antiviral therapy ] [ Designated as safety issue: No ]serum ALT <40 IU/mL
- Serum level of HBsAg [ Time Frame: Within one month after completion of antiviral therapy ] [ Designated as safety issue: No ]quantification of serum HBV serface antigen
- Serious adverse reaction [ Time Frame: Within one month after completion of antiviral therapy ] [ Designated as safety issue: Yes ]Defined as death, life threatening event, permanent or temporary disability, and hospitalization
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TDF
tenofovir disoproxil fumarate (TDF) 300mg
|
Drug: tenofovir disoproxil fumarate 300mg per day
tenofovir disoproxil fumarate 300mg per day for 3 years
Other Name: Viread® (Gilead Sciences Inc)
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo, identical to TDF in appearance, once daily for 3years
|
Detailed Description:
Chronic hepatitis B (CHB) is a serious disease in Taiwan, leading to substantial morbidity and mortality including hepatic failure, liver cirrhosis, and hepatocellular carcinoma (HCC). Recently a large body of evidence supports that high level of serum HBV DNA is an independent risk factor for late complications in CHB patients. Nucleos(t)ide analogues (NUC) are effective antiviral therapy that can potently inhibit replication of hepatitis B virus (HBV), and has been widely used in management of patients with CHB. Current practice guidelines recommend using serum alanine aminotransferase (ALT) > 2 times of the upper limit of normal (ULN) as the prerequisite to initiate antiviral therapy in compensated CHB patients without liver cirrhosis. However, serum ALT level does not exactly correlate with serum HBV DNA or liver tissue injury. Whether antiviral therapy improves outcomes of patients with slightly elevated ALT (i.e. 1-2 folds of ULN) remains unknown.
Eligibility| Ages Eligible for Study: | 25 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age between 25 to 70 years,
- serum HBsAg positivity for more than 6 months,
- positive or negative serum HBeAg,
- serum HBV DNA more than 2,000 IU/mL,
- highest serum ALT > 1 fold of ULN, but < 2 X ULN on at least two occasions (≧ 3 months apart) in the preceding one year,
Exclusion Criteria:
- co-infection with HIV, HCV, or HDV,
- previous exposure to HBV antiviral therapy for more than 12 weeks,
- presence of cirrhosis on histopathology,
- hepatic decompensation defined as serum bilirubin > 2mg/dl and prolonged prothrombin time > 3 seconds,
- concurrent malignant diseases including hepatocellular carcinoma,
- severe co-morbidity with life expectancy < 1year,
- pregnant or lactating women,
- organ transplantation except cornea or hair transplant,
- suspected or confirmed chronic liver diseases from etiologies other than HBV (e.g. alcoholic hepatitis, Wilson disease, Hemochromatosis…etc),
- serum creatinine >1.5mg/dL
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522625
Contacts
| Contact: Jaw-Town Lin, MD,PhD. | 886-2-23123456 ext 62246 | jawtown@ntu.edu.tw |
| Contact: Yao-Chun Hsu, MD, MSc | 886-7-6150011 ext 2980 | gatsbyhsu@yahoo.com.tw |
Locations
| Taiwan | |
| Chia-Yi Christine Hospital | Recruiting |
| Chia-Yi, Taiwan, 539 | |
| Contact: Chi-Yi Chen, MD 886-5-2765041 01290@cych.org.tw | |
| E-Da Hospital | Recruiting |
| Kaohsiung, Taiwan, 824 | |
| Contact: Yao-Chun Hsu, MD, MSc 886-7-6150011 ext 2980 gatsbyhsu@yahoo.com.tw | |
| Taichung Veterans General Hospital | Recruiting |
| Taichung, Taiwan, 407 | |
| Contact: Chun-Ying Wu, MD, PhD 886-4-23592525 dr.taiwan@yahoo.com.tw | |
| Chi Mei Medical Center, Liouying | Active, not recruiting |
| Tainan, Taiwan | |
| Mackay Memorial Hosp | Not yet recruiting |
| Taipei, Taiwan, 104 | |
| Contact: Wen-Hsiung Chang, MD 02-2543-3535 d220533864@yahoo.com.tw | |
| National Taiwan University Hospital Yun-Lin Branch | Recruiting |
| Yunlin County, Taiwan, 640 | |
| Contact: Chieh-Chang Chen, MD chiehchang.chen@gmail.com | |
| Principal Investigator: Chieh-Chang Chen, MD | |
Sponsors and Collaborators
E-DA Hospital
Gilead Sciences
Taipei Institute of Pathology, Taiwan
Investigators
| Principal Investigator: | Yao-Chun Hsu, MD, MSc | E-Da Hospital, Kaohsiung, Taiwan |
| Study Chair: | Jaw-Town Lin, MD, PhD | National Taiwan University |
More Information
No publications provided
| Responsible Party: | Hung Chi Chen, superintendent, E-DA Hospital |
| ClinicalTrials.gov Identifier: | NCT01522625 History of Changes |
| Other Study ID Numbers: | EMRP36100N |
| Study First Received: | January 27, 2012 |
| Last Updated: | October 14, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by E-DA Hospital:
|
chronic hepatitis B hepatitis B viral DNA antiviral therapy Tenofovir |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
DNA Virus Infections Tenofovir Tenofovir disoproxil Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 16, 2013