Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04539652
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arm: 1
• Actual Duration (Months): 33.1
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

This study was designed to evaluate the rate of subjects with HBV DNA less than 20 IU/mL after taking TenofoBell® tablet for 48 weeks

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: Experimental	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Single-Arm, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients in Treatment of Oral Antiviral Therapy for Hepatitis B Virus
• Actual Study Start Date: Sep 20, 2018
• Actual Primary Completion Date: Jun 22, 2021
• Actual Study Completion Date: Jun 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group	Drug: Experimental; Experimental group are treated with TenofoBell®

Outcome Measures

Primary Outcome Measures

1. Rate of subjects with HBV DNA less than 20 IU/mL [change after 48 weeks compared to baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

1. Inclusion Criteria:

2. Patients who show positive HBsAg

3. Patients who show positive or negative HBeAg

4. Exclusion Criteria:

5. Patients who have hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV)

6. Patients with a history of allergic reaction to Tenofovir

7. Patients who are unable to participate in clinical trials based on investigator's decision.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daegu Chatholic University Medical center	Daegu		Korea, Republic of

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT04539652
• Other Study ID Numbers: 285HBV18018
• First Posted: Sep 7, 2020
• Last Update Posted: Jul 28, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic

Study Results

No Results Posted as of Jul 28, 2021