## Protocol Section
### Identification Module
**NCT ID:** NCT01743079

**Brief Title:** Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B

**Official Title:** The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission

#### Organization Study ID Info
**ID:** 20080810
#### Organization
**Class:** OTHER
**Full Name:** Beijing YouAn Hospital
### Status Module
#### Completion Date
**Date:** 2013-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-07-30

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-07-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-07

**Type:** ACTUAL

#### Start Date
**Date:** 2009-01

**Status Verified Date:** 2013-07

#### Study First Post Date
**Date:** 2012-12-06
**Type:** ESTIMATED
**Study First Submit Date:** 2012-12-03
**Study First Submit QC Date:** 2012-12-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** New Discovery LLC

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing YouAn Hospital

#### Responsible Party

**Investigator Affiliation:** Beijing YouAn Hospital

**Investigator Full Name:** Hua Zhang

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

**Detailed Description:** This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA \> 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.

### Conditions Module

**Conditions:**

- Chronic Hepatitis B

- Late Pregnancy

- Transmission

- Complication

**Keywords:**

- Telbivudine

- Lamivudine

- safety

- efficacy

- pregnancy

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 700

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis

**Intervention Names:**

- Drug: Telbivudine

**Label:** Telbivudine

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis.

**Intervention Names:**

- Drug: Lamivudine

**Label:** Lamivudine

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis

**Label:** No antiviral treatment

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Telbivudine

**Description:** LdT 600mg QD

**Name:** Telbivudine

**Other Names:**

- LdT

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Lamivudine

**Description:** LAM 100mg QD

**Name:** Lamivudine

**Other Names:**

- LAM

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child

**Time Frame:** From gestation week 26 to postpartum week 52

#### Secondary Outcomes

**Measure:** percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion

**Time Frame:** From gestation week 26 to pastpartume week 52

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age: 20-40 years old
2. HBsAg, HBeAg positive and HBV DNA \>6 log10 copies/ml
3. Gestational age: 26-28 weeks with normal fetus
4. Willing to consent for the study

Exclusion Criteria:

1. Elevated ALT
2. Antiviral treatment experience patients
3. Co-infection with HAV, HCV,HDV, HIV
4. Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
5. Clinical signs of threatened miscarriage in early pregnancy
6. Clinical evidence of cirrhosis and/or hepatocellular carcinoma

**Maximum Age:** 40 Years

**Minimum Age:** 20 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** Beijing YouAn Hospital

**State:** Beijing

**Zip:** 100069

#### Overall Officials

**Official 1:**

**Affiliation:** Division of Liver Diseases, Mount Sinai School of Medicine, Flushing, NY

**Name:** Calvin Pan, MD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Beijing YouAn Hospital

**Name:** Hua Zhang, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Zhang H, Pan CQ, Pang Q, Tian R, Yan M, Liu X. Telbivudine or lamivudine use in late pregnancy safely reduces perinatal transmission of hepatitis B virus in real-life practice. Hepatology. 2014 Aug;60(2):468-76. doi: 10.1002/hep.27034.

**PMID:** 25187919

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018347

- Term: Hepadnaviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000006521

- Term: Hepatitis, Chronic

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9595

- Name: Hepatitis B

- Relevance: HIGH

- As Found: Hepatitis B

- ID: M21609

- Name: Hepatitis B, Chronic

- Relevance: HIGH

- As Found: Chronic Hepatitis B

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9607

- Name: Hepatitis, Chronic

- Relevance: LOW

- As Found: Unknown

- 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

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20487

- Name: Hepadnaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006509

- Term: Hepatitis B

- ID: D000019694

- Term: Hepatitis B, Chronic

- ID: D000006505

- Term: Hepatitis

### 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

### Intervention Browse Module - Browse Leaves

- ID: M21243

- Name: Lamivudine

- Relevance: HIGH

- As Found: Plane

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- 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: D000077712

- Term: Telbivudine

### Misc Info Module

- Version Holder: 2024-05-24
