Boceprevir Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials evaluate boceprevir across therapeutic and pharmacokinetic contexts, primarily focusing on hepatitis C virus (HCV) infection, liver transplantation in HCV-infected patients, and related thrombocytopenia. Ranging from Early Phase 1 to Phase 2/3, these studies involve academic sponsors—including Indiana University, Imperial College London, and UT Southwestern—and industry partners such as GlaxoSmithKline and Merck Sharp & Dohme. Recorded recruitment statuses include completed investigations of drug-drug interactions and pre-transplantation antiviral clearing, alongside terminated studies examining combination regimens.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01909401	Completed	Liver Transplantation	Indiana University\|Merck Sharp & Dohme LLC	2013-06	Early Phase 1
NCT01821625	Terminated	Thrombocytopenia\|Hepatitis C	University of Texas Southwestern Medical Center\|GlaxoSmithKline	2013-04	Phase 2\|Phase 3
NCT01499498	Completed	Hepatitis C	Imperial College London	2012-12	Phase 1
NCT01663922	Completed	Hepatitis C	St Stephens Aids Trust\|University of Liverpool\|University of Turin Italy	2012-08	Phase 1
NCT01657552	Completed	Thrombocytopaenia	GlaxoSmithKline	2012-08-01	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Boceprevir selectively binds to the hepatitis C virus NS3/4A serine protease with a Ki value of 14 nM, inhibiting the enzymatic cleavage of viral polyproteins required for HCV replication. By suppressing viral protein processing and assembly within infected host cells, this targeted protease inhibition reduces systemic viral load, offering therapeutic efficacy in managing chronic hepatitis C virus infection and mitigating viral recurrence in liver transplantation settings.

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>).