Clinical Trials

Several clinical trials are evaluating healthcare strategies and regimens for hepatitis C virus infection, HIV co-infection, substance use disorders, and acute bacterial complications such as soft tissue infection, bacteremia, osteomyelitis, and septic arthritis. Sponsored by academic and research institutions including ANRS Emerging Infectious Diseases, the Kirby Institute, Institut Pasteur, and the University of Maryland Baltimore, these studies incorporate Phase 4, non-applicable interventional, and unassigned phase designs. Comprising both recruiting and not yet recruiting studies, these investigations focus on optimizing therapeutic management and healthcare transitions across viral and bacterial infections.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05506475 Not yet recruiting
HIV Infection|Hepatitis C Infection
Institut Pasteur|National Institute of Hygiene and Epidemiology Vietnam|ANRS Emerging Infectious Diseases
2024-05 --
NCT05521880 Not yet recruiting
Substance Use Disorders|Infection Soft Tissue|Bacteremia|Osteomyelitis Acute|Septic Arthritis
University of Maryland Baltimore
2024-05 Phase 4
NCT05992077 Recruiting
HCV Infection
ANRS Emerging Infectious Diseases
2023-08-07 Not Applicable
NCT05713136 Not yet recruiting
Hepatitis C
Kirby Institute
2023-08-14 --
NCT05248555 Recruiting
Hepatitis C
Kirby Institute
2023-01-16 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dehydroabietic acid suppresses pro-inflammatory cascades by inhibiting the signaling pathways mediated by Src, Syk, and TAK1 kinases, which consequently reduces cellular inflammatory mediator release and tissue damage. This modulation of immune signaling provides clinical relevance in mitigating excessive inflammatory responses associated with severe bacterial and viral infections such as hepatitis C, bacteremia, and septic arthritis.

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>).

Note: Technical data last updated: Sep 1, 2026.