An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
This study is ongoing, but not recruiting participants.
Sponsor:
Bukwang Pharmaceutical
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01264354
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012
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Purpose
This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B |
Drug: Clevudine 30mg Drug: Clevudine 20mg+Adefovir dipivoxil 10mg Drug: Clevudine 20mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B |
Resource links provided by NLM:
Further study details as provided by Bukwang Pharmaceutical:
Primary Outcome Measures:
- Proportion of patients with HBV DNA levels < 300 copies/mL [ Time Frame: 24 week ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The change of HBV DNA form the baseline [ Time Frame: 24week, 48week, 96week ] [ Designated as safety issue: No ](log copies/mL)
- Proportion of patients with HBV DNA < 300 copies/mL [ Time Frame: 48week, 96week ] [ Designated as safety issue: No ]
- Proportion of patients with ALT normalization [ Time Frame: 24week, 48week, 96week ] [ Designated as safety issue: No ]
- Proportion of patients with HBeAg loss and/or seroconversion [ Time Frame: 96 Week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Clevudine 30mg
|
Drug: Clevudine 30mg
Clevudine 30mg
Other Name: Levovir 30mg
|
|
Experimental: 2
Clevudine 20mg+Adefovir dipivoxil 10mg
|
Drug: Clevudine 20mg+Adefovir dipivoxil 10mg
Clevudine 20mg+ Adefovir 10mg
Other Name: Levovir 20mg+Adefovir 10mg
|
|
Experimental: 3
Clevudine 20mg
|
Drug: Clevudine 20mg
Clevudine 20mg
Other Name: Levovir 20mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is 18 years and older.
- Patient is documented to be HBsAg positive for > 6 months.
- Patient is HBV DNA positive with DNA levels ≥ 1×10^5 copies/mL within 30days of baseline.
- Patient has ALT levels ≥ 1×ULN
- Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria:
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
- Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, Tenofovir or any other investigational nucleoside for HBV infection.
- Patient with clinical evidence of decompensated liver disease (Total bilirubin < 2.0mg/dL, Prothrombin time < 1.7(INR), Serum albumin≥3.5g/dL)
- Patient is coinfected with HCV, HDV or HIV.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient with clinical evidence of hepatocellular carcinoma
- Patient with previous liver transplantation
- Patient is pregnant or breast-feeding.
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient has a significant immunocompromised, gastrointestinal, renal,
- hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
- Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Byung Chul Yoo/Samsung Medical Center, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01264354 History of Changes |
| Other Study ID Numbers: | CLV-412 |
| Study First Received: | December 19, 2010 |
| Last Updated: | July 24, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
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 2'-fluoro-5-methylarabinosyluracil Adefovir Adefovir dipivoxil Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on June 13, 2013