## Protocol Section
### Identification Module
**NCT ID:** NCT01693679

**Brief Title:** Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis

#### Organization Study ID Info
**ID:** Telbivudine
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2012-09-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-09-24

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2014-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2012-09

**Status Verified Date:** 2012-09

#### Study First Post Date
**Date:** 2012-09-26
**Type:** ESTIMATED
**Study First Submit Date:** 2012-09-20
**Study First Submit QC Date:** 2012-09-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shao-quan Zhang

#### Responsible Party

**Investigator Affiliation:** Sun Yat-sen University

**Investigator Full Name:** Shao-quan Zhang

**Investigator Title:** Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** • To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver cirrhosis.

### Conditions Module

**Conditions:**

- HBV-related Liver Cirrhosis

**Keywords:**

- Tebivudine eGFR non-Tebivudine

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Telbivudine team,Telbivudine,600mg/d,oral,60 patients. non-Tebivudine team,Lamivudine,100mg/d,oral,20 patients.Adefovir,10mg/d,oral,20 patients.Enecavir,0.5mg/d,oral,20 patients.

**Intervention Names:**

- Drug: Telbivudine, Lamivudine, Adefovir ,Enecavir

**Label:** antiviral drug

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- antiviral drug

**Description:** investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.

**Name:** Telbivudine, Lamivudine, Adefovir ,Enecavir

**Other Names:**

- no.

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** No.

**Measure:** Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks

**Time Frame:** May 2014

#### Secondary Outcomes

**Description:** No.

**Measure:** Change from Baseline in ALT normalization rate,• The rate of complications,• Percentage of participants with HBeAg loss & HBeAg seroconversion and Percentage of subjects achieving HBV DNA<300copies/mL at96 weeks

**Time Frame:** May 2014

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Subjects eligible for enrolment in the study must meet all of the following criteria:

* Aged between 18-75 years (inclusive).
* Male or female.
* Subjects with positive HBsAg for more than 6 months and anti-HBs negative regardless of HBeAg status , HBV DNA ≥2×103 IU/ml
* Subjects with HBV-related liver cirrhosis, including compensated cirrhosis and decompensated, but only Child-Pugh A or B.
* The ablility to understand and sign a written informed consent prior to any study related procedure and comply with the requirements of the study.

Exclusion Criteria:

* Subjects meeting any of the following criteria must not be enrolled in the study

  * Subjects with non-HBV cirrhosis
  * Co-infection with HAV/HCV/HDV/ HIV
  * Subjects who take nucleosides within 6 months
  * Kidney injury due to non-HBV factors
  * Inability to comply with study requirements as determined by the study investigator
  * Patients with very low GFR, who may need dialysis or renal transplantation

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11103

- Name: Liver Cirrhosis

- Relevance: HIGH

- As Found: Liver Cirrhosis

- ID: M8485

- Name: Fibrosis

- Relevance: HIGH

- As Found: Cirrhosis

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008103

- Term: Liver Cirrhosis

- ID: D000005355

- Term: Fibrosis

### Intervention Browse Module - Ancestors

- ID: D000018894

- Term: Reverse Transcriptase Inhibitors

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000019380

- Term: Anti-HIV Agents

- ID: D000044966

- Term: Anti-Retroviral Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

### Intervention Browse Module - Browse Leaves

- ID: M21243

- Name: Lamivudine

- Relevance: HIGH

- As Found: Plane

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M219518

- Name: Adefovir

- Relevance: HIGH

- As Found: IV bolus

- ID: M1879

- Name: Telbivudine

- Relevance: HIGH

- As Found: 3 times per day

- ID: M20935

- Name: Reverse Transcriptase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21350

- Name: Anti-HIV Agents

- Relevance: LOW

- As Found: Unknown

- ID: M25428

- Name: Anti-Retroviral Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000019259

- Term: Lamivudine

- ID: C000053001

- Term: Adefovir

- ID: D000077712

- Term: Telbivudine

### Misc Info Module

- Version Holder: 2024-05-24
