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)
Mechanism and Biochemical Profile
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>).
- Dehydroabietic acid Solubility in DMSO
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- Dehydroabietic acid Molecular Weight
- Dehydroabietic acid SMILES
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- Dehydroabietic acid Chemical Structure (2D and 3D)
- Dehydroabietic acid SDS|MSDS