Ombitasvir (ABT-267) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 457

Clinical Trials

Several clinical trials have evaluated Ombitasvir (ABT-267) across Phase 1, Phase 2, Phase 4, and unassigned phases, with all studies reaching completed recruitment status. Sponsored by pharmaceutical entities such as AbbVie in collaboration with academic organizations like the Ottawa Hospital Research Institute, these trials involved healthy volunteers as well as patients with chronic and general hepatitis C virus infection. The investigations focused on pharmacokinetics, multi-dose tolerability, therapy durability, combination antiviral efficacy, and metabolic parameters, including lipid and insulin profiles.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02581020	Completed	Hepatitis C Virus	AbbVie	2016-01-14	--
NCT02534870	Completed	Healthy Volunteer	AbbVie	2015-09	Phase 1
NCT02734173	Completed	Hepatitis C	Ottawa Hospital Research Institute\|AbbVie	2015-07	Phase 4
NCT01911845	Completed	Chronic Hepatitis C Infection\|Chronic Hepatitis C	AbbVie	2013-04	Phase 2

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

Check the Ombitasvir (ABT-267) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ombitasvir selectively binds to the hepatitis C virus non-structural protein 5A (NS5A), thereby inhibiting essential viral RNA replication complex assembly and hyperphosphorylation required for genomic amplification. This disruption of viral protein function impairs HCV replication within host hepatocytes, ultimately providing clinical relevance by suppressing viral load and contributing to sustained virologic response in chronic hepatitis C 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>).