Entecavir Hydrate Clinical Trials

Size	Price	Qty
10mg	USD 197
50mg	USD 397

Clinical Trials

Multiple clinical trials are currently recruiting participants to evaluate entecavir hydrate in chronic hepatitis B and pediatric hydrocephalus cohorts, although specific trial phases are not formally reported. Sponsored by academic and corporate entities—including Sohag University, Boston Children's Hospital, Yale University, and Jiangsu Hansoh Pharmaceutical Co. Ltd.—these active studies focus on therapeutic efficacy, safety, viral suppression, and developmental outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05874440	Recruiting	Chronic Hepatitis b Patients	Sohag University	2023-04-15	--
NCT05755776	Recruiting	Chronic Hepatitis B	The Second Affiliated Hospital of Chongqing Medical University\|Jiangsu Hansoh Pharmaceutical Co. Ltd.	2023-03-01	--
NCT03650101	Recruiting	Hydrocephalus	Boston Children''s Hospital\|The Hospital for Sick Children\|CURE Children''s Hospital Uganda\|Yale University	2021-05-05	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Entecavir hydrate is a deoxyguanine nucleoside analogue that competitively binds to hepatitis B virus polymerase to inhibit viral reverse transcription, DNA synthesis, and gene transcription. By blocking these critical steps in viral replication, the compound prevents viral propagation and reduces circulating viral burden, providing the mechanistic basis for its therapeutic use in treating chronic hepatitis B virus infection.

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>).