MedPath

Clevudine

Generic Name
Clevudine
Drug Type
Small Molecule
Chemical Formula
C10H13FN2O5
CAS Number
163252-36-6
Unique Ingredient Identifier
IN51MVP5F1

Overview

No overview information available.

Indication

用于慢性乙型肝炎(简称乙肝)的治疗。

Associated Conditions

  • Viral Hepatitis B

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate COVID-19
2021/05/18
NCT04891302
Phase 2
Completed
Bukwang Pharmaceutical
The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19
2020/04/15
NCT04347915
Phase 2
Completed
Bukwang Pharmaceutical
A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients
2010/12/24
NCT01266005
Phase 4
Terminated
Bukwang Pharmaceutical
A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+)
2010/12/21
NCT01264367
Phase 4
Completed
Bukwang Pharmaceutical
An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
2010/12/21
NCT01264354
Phase 4
Completed
Bukwang Pharmaceutical
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
2010/12/21
NCT01264094
Phase 4
Terminated
Bukwang Pharmaceutical
An Study of Efficacy and Safety of Clevudine
2010/09/01
NCT01192854
Phase 3
Completed
Eisai Co., Ltd.
ANRS HB 05 Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus Combination Therapy of Clevudine and Tenofovir for 96 Weeks in HBeAg Negative Patients With Chronic Hepatitis B, naïve to Anti-VHB Therapy
2009/01/15
NCT00823342
Phase 3
Terminated
French National Agency for Research on AIDS and Viral Hepatitis
Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients
2008/11/26
NCT00798460
Phase 4
Terminated
Inje University
A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B
2008/05/06
NCT00672867
Phase 3
Completed
Bukwang Pharmaceutical

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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