Ledipasvir acetone Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Several clinical trials evaluate ledipasvir-based therapeutic regimens for chronic hepatitis C virus infection, primarily focusing on pediatric cohorts, including patients with concurrent hematologic malignancies. Spanning Phase 1, Phase 2, and non-assigned phases, these studies are sponsored by academic institutions such as Ain Shams University, Cairo University, and Mansoura University Children Hospital, as well as federal sponsors like the National Cancer Institute and National Institutes of Health Clinical Center. Portfolio status includes both completed and withdrawn trials, with completed studies assessing the safety, efficacy, and pharmacokinetics of ledipasvir combined with sofosbuvir.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03903185	Completed	Hepatitis C Chronic\|Hematologic Malignancy	Ain Shams University\|Cairo University	2019-03-01	Phase 1\|Phase 2
NCT03639207	Withdrawn	Hepatitis C Virus	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2018-06-15	--
NCT05091008	Completed	Hepatitis C Chronic	Mansoura University Children Hospital	2018-03-01	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ledipasvir acts as a potent inhibitor by directly binding to the non-structural protein 5A (NS5A) of the hepatitis C virus, thereby disrupting viral hyperphosphorylation and RNA replication assembly complexes. This targeted biochemical inhibition blocks viral genome replication and virion assembly in infected hepatocytes, which underlies its clinical efficacy in achieving sustained virologic response in patients with chronic hepatitis C 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>).