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NCT01995071
A Randomized, Open-Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-493 and ABT-530 in Adult Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Phase 2 trial testing ABT-493 in Chronic Hepatitis C in 89 participants. Completed in 1 June 2015.
1 June 2015
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 89 |
| Start date | 1 November 2013 |
| Primary completion | 1 June 2015 |
| Estimated completion | 1 June 2015 |
Drugs / interventions tested
- ABT-493 — full drug profile →
- ABT-530 — full drug profile →
- ABT-450/r/ABT-267, ABT-333 — full drug profile →
- Ribavirin (RBV) — full drug profile →
Conditions studied
- Chronic Hepatitis C — all drugs for Chronic Hepatitis C →
- Hepatitis C Virus — all drugs for Hepatitis C Virus →
- Compensated Cirrhosis — all drugs for Compensated Cirrhosis →
Sponsor
AbbVie — full company profile →
Who can join
Adults 18 to 70, any sex, with Chronic Hepatitis C or Hepatitis C Virus. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment
Time frame: Day 1 through prior to first dose of the combination regimen on Study Day 4
Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1.
Sponsor's own description
The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection.
Lawitz EJ, O'Riordan WD, Asatryan A, Freilich BL, et al · · 2015 · cited 34× · PMID 26711747 · DOI 10.1128/aac.02264-15 -
Resistance Analysis of a 3-Day Monotherapy Study with Glecaprevir or Pibrentasvir in Patients with Chronic Hepatitis C Virus Genotype 1 Infection.
Ng TI, Pilot-Matias T, Tripathi R, Schnell G, et al · · 2018 · cited 1× · PMID 30154359 · DOI 10.3390/v10090462
Verify or expand the search:
- PubMed search for NCT01995071
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ABT-493
Trials testing the same drug.
- NCT02441283 — A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530 · Phase 2, PHASE3 · completed
- NCT02243293 — A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and With · Phase 2, PHASE3 · completed
Other recruiting trials for Chronic Hepatitis C
Currently open trials in the same condition.
- NCT06180590 — The Efficacy of Vosevi in Treating DAA-experienced Patients · recruiting
- NCT03993925 — Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong · active not recruiting
Other AbbVie trials
Trials by the same sponsor.
- NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
- NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
- NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
- NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
- NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01995071 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AbbVie
- Last refreshed: 8 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01995071.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing