Status:
UNKNOWN
A Study to Investigate the Safety, Efficacy and PK of Multiple Doses of QL-007 in Chronic Hepatitis B Patients in CHINA
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a randomized, open-label, positive-control, dose-escalation Phase 1b trial in 60 patients with chronic HBV infection to determine the safety, preliminary efficacy, and pharmacokinetics (PK) of...
Detailed Description
This is a randomized, open-label, positive-control, dose-escalation Phase 1b trial in 60 patients with chronic HBV infection to determine the safety, preliminary efficacy, and pharmacokinetics (PK) of...
Eligibility Criteria
Inclusion
- Chronic Hepatitis B infection, defined as positive test for Hepatitis B surface antigen (HBsAg) for more than 6 months prior to randomization
- HBV DNA at screening greater than or equal to (\>/=) 2 × 10\^4 international units per milliliter (IU/mL) for Hepatitis B e antigen (HBeAg) positive participants, or \>/=2 × 10\^3 IU/mL for HBeAg-negative participants
- ALT\> 1 x upper limit of normal (ULN) and \< 10 x upper limit of normal (ULN)
- Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥4 weeks prior to screening are also eligible.
- Signed informed consent.
Exclusion
- Known co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
- Presence of autoimmune disorders
- History of liver disease other than Hepatitis B
- History of Gilbert's Disease
- Any sign of decompensated liver disease
- Known or suspected cirrhosis
- Evidence of hepatocellular carcinoma
- Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)
- Pregnant or lactating females
- Diabetes
- Alcohol or substance abuse
- History of bleeding diathesis
- Patients with a history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator.
- History of clinically significant gastrointestinal, cardiovascular, endocrine, renal, ocular, pulmonary, psychiatric or neurological disease.
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03770624
Start Date
October 16 2018
End Date
April 30 2019
Last Update
December 10 2018
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034