Telbivudine Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Several clinical trials evaluate telbivudine across patient cohorts affected by viral liver diseases, focusing on chronic hepatitis B, compensated chronic hepatitis B, HBsAg-positive renal allograft recipients, and pediatric populations. Ranging from Phase 1 safety evaluations and Phase 4 post-marketing studies to non-phased observational research, these investigations were sponsored by entities including Novartis Pharmaceuticals, Hoffmann-La Roche, and National Taiwan University Hospital. The clinical portfolio consists primarily of completed trials alongside terminated studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02956850	Completed	Hepatitis B Chronic	Hoffmann-La Roche	2016-12-12	Phase 1
NCT02894554	Terminated	HBsAg-positive Renal Allograft Recipients	National Taiwan University Hospital	2014-07	Phase 4
NCT01379508	Completed	Chronic Hepatitis B	Novartis Pharmaceuticals\|Novartis	2011-03-21	Phase 4
NCT01163240	Completed	Liver Diseases\|Hepatitis Chronic\|Hepatitis Viral Human\|Hepatitis\|Virus Diseases\|Digestive System Diseases\|Hepatitis B Chronic\|Hepatitis B\|DNA Virus Infections	Novartis Pharmaceuticals\|Novartis	2009-06	--
NCT00877149	Completed	Compensated Chronic Hepatitis B	Novartis Pharmaceuticals\|Novartis	2009-03	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Telbivudine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Telbivudine is a synthetic thymidine nucleoside analogue that selectively inhibits hepatitis B virus (HBV) reverse transcriptase, thereby blocking viral DNA chain elongation and halting viral synthesis within infected hepatocytes. By suppressing active viral replication, telbivudine reduces hepatic viral load and mitigates progressive viral liver pathology in patients with chronic hepatitis B.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).