A Study With 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:
NCT01264133
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012
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Purpose
An open study to Evaluate the Efficacy, Safety and Sustained effect of Clevudine monotherapy or Adefovir and Clevudine combination in proportion to Roadmap concept in Patients with chronic hepatitis B.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B |
Drug: Clevudine, Adefovir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Study to Evaluate the Efficacy, Safety and Sustained Effect of Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept 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 < 60 IU/mL [ Time Frame: 48 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Clevudine, Adefovir
Clevudine 30mg qd or Clevudine 30mg + Adefovir 10mg qd
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 ≥ 2,000 IU/mL within 30 days of baseline.
- Patient has ALT levels >=80 IU/L
- Patient with compensated liver disease (Patient with chronic B Hepatitis or liver cirrhosis <= 6)
- 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 or any other investigational nucleoside for HBV infection.
- Patient is coinfected with HCV, HDV or HIV.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient with clinical evidence of decompensated liver disease or 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: | Byungchul Yoo, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01264133 History of Changes |
| Other Study ID Numbers: | CLV-411, CLV-411 |
| Study First Received: | December 19, 2010 |
| Last Updated: | July 24, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
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 May 22, 2013