Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 have evaluated the therapeutic profile and clinical utility of telaprevir (VX-950) in chronic hepatitis C virus infection and associated complications, including co-occurring depression or HIV co-infection. Sponsored by major pharmaceutical companies—such as Vertex Pharmaceuticals, Janssen Pharmaceutica, Mitsubishi Tanabe Pharma, and Hoffmann-La Roche—alongside academic medical centers, these completed, terminated, and withdrawn protocols assessed telaprevir combination regimens with peginterferon, ribavirin, or sofosbuvir to optimize safety and viral clearance.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02087111 COMPLETED
Hepatitis C
Queen Mary University of London
 2014-04 PHASE4
NCT01858961 WITHDRAWN
Hepatitis C, Chronic
Boehringer Ingelheim
 2013-05 PHASE3
NCT02006745 COMPLETED
HIV
St Stephens Aids Trust
 2014-01 PHASE3
NCT01890772 WITHDRAWN
Hepatitis C
Timothy Morgan, MD
 2013-08 PHASE2; PHASE3
NCT01532908 TERMINATED
Hepatitis C Infection
MassBiologics
 2012-11-21 PHASE2
NCT01701063 TERMINATED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2013-01 PHASE1; PHASE2
NCT01598090 COMPLETED
Hepatitis C Virus
Bristol-Myers Squibb
 2012-06-14 PHASE3
NCT01872936 UNKNOWN
Hepatitis C, Chronic
Santaris Pharma A/S
 2013-06 PHASE2
NCT01854697 COMPLETED
Chronic Hepatitis C Infection
AbbVie
 2013-03 PHASE3
NCT01854528 COMPLETED
Chronic Hepatitis C Infection
AbbVie
 2013-06 PHASE3
NCT01704521 COMPLETED
Chronic Hepatitis C; Hemophilia
Kenneth Sherman
 2012-12 PHASE1
NCT01718158 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2013-01 PHASE3
NCT01592006 TERMINATED
Hepatitis C
University of Chicago
 2012-04 PHASE4
NCT01841502 TERMINATED
Hepatitis C Infection; Depression
Radboud University Medical Center
 2013-05 PHASE2
NCT01500616 COMPLETED
Hepatitis C, Chronic
Janssen-Cilag International NV
 2012-06 PHASE3
NCT01648140 COMPLETED
Hepatitis C, Chronic
GlaxoSmithKline
 2012-08-01 PHASE2
NCT01766115 WITHDRAWN
Viral Hepatitis C
Massachusetts General Hospital
 2013-04 PHASE4
NCT01467492 TERMINATED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2012-01 PHASE4
NCT01571583 COMPLETED
Chronic Hepatitis C Virus (HCV) Infection
Janssen-Cilag International NV
 2012-02 PHASE3
NCT01994486 COMPLETED
Hepatitis C, Chronic
University of Florida
 2013-12 PHASE2
NCT01467505 TERMINATED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2012-02 PHASE2
NCT01513941 COMPLETED
Chronic Hepatitis C
Janssen-Cilag International NV
 2012-04 PHASE3
NCT02881034 Completed
Hepatitis C
Hospices Civils de Lyon
 2014-02 --
NCT01467479 TERMINATED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2011-12 PHASE3
NCT01355289 COMPLETED
Thrombocytopenia
Eisai Inc.
 2011-11 PHASE2
NCT01821963 TERMINATED
Infection
M.D. Anderson Cancer Center
 2013-04 PHASE3
NCT01482390 COMPLETED
Hepatitis C
Hoffmann-La Roche
 2011-11-30 PHASE2
NCT01459913 TERMINATED
Hepatitis C, Chronic
Vertex Pharmaceuticals Incorporated
 2011-11 PHASE3
NCT01718145 COMPLETED
Hepatitis C Virus Infection
Bristol-Myers Squibb
 2012-11 PHASE3
NCT01994486 Completed
Hepatitis C Chronic
University of Florida|Vertex Pharmaceuticals Incorporated
 2013-12 Phase 2
NCT01492426 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2012-01 PHASE3
NCT01582035 COMPLETED
Hepatitis C
Janssen R&D Ireland
 2012-04 PHASE1
NCT01080222 TERMINATED
Chronic Hepatitis C Virus Infection
Vertex Pharmaceuticals Incorporated
 2010-08 PHASE2
NCT01516918 COMPLETED
Chronic Hepatitis C Virus
Vertex Pharmaceuticals Incorporated
 2012-02 PHASE2
NCT01332955 COMPLETED
Hepatitis C, Chronic; HIV Infection
ANRS, Emerging Infectious Diseases
 2011-04 PHASE2
NCT01581138 COMPLETED
Chronic Hepatitis C Virus
Vertex Pharmaceuticals Incorporated
 2012-07 PHASE2
NCT01980290 Completed
Hepatitis Chronic
Janssen Pharmaceutica N.V. Belgium
 2013-05 --
NCT01841502 Terminated
Hepatitis C Infection|Depression
Radboud University Medical Center|Janssen LP
 2013-05 Phase 2
NCT01818856 COMPLETED
Hepatitis C, Chronic; HIV Infection
Hospitales Universitarios Virgen del Rocío
 2012-12 PHASE1
NCT02113631 COMPLETED
Hepatitis C, Chronic; Cirrhosis
Louis Stokes VA Medical Center
 2011-09
NCT01786382 COMPLETED
Pharmacokinetic Assessments in Healthy Volunteers
Presidio Pharmaceuticals, Inc.
 2013-02 PHASE1
NCT01766167 Completed
Chronic Hepatitis C
Mitsubishi Tanabe Pharma Corporation
 2013-02 Phase 1
NCT00892697 COMPLETED
Hepatitis C
Weill Medical College of Cornell University
 2009-05 PHASE2
NCT01657552 COMPLETED
Thrombocytopaenia
GlaxoSmithKline
 2012-08-01 PHASE1
NCT01600976 COMPLETED
Hepatic Impairment
Janssen Infectious Diseases BVBA
 2012-06 PHASE1
NCT01646489 COMPLETED
Hepatitis C; Chronic Hepatitis C
Santaris Pharma A/S
 2012-06 PHASE1
NCT01241760 COMPLETED
Genotype 1 Chronic Hepatitis C; Treatment Naive
Janssen Infectious Diseases BVBA
 2010-12 PHASE3
NCT01635829 COMPLETED
Healthy Participants
Janssen Infectious Diseases BVBA
 2012-05 PHASE1
NCT01597895 COMPLETED
Healthy
ViiV Healthcare
 2012-07 PHASE1
NCT01511432 COMPLETED
Chronic Hepatitis C
Vertex Pharmaceuticals Incorporated
 2012-01 PHASE1
NCT01563328 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2012-03-01 PHASE1
NCT01498068 COMPLETED
Genotype 1 Chronic Hepatitis C
Janssen-Cilag International NV
 2012-01 PHASE3
NCT00983853 COMPLETED
Hepatitis C; HIV Infections
Vertex Pharmaceuticals Incorporated
 2009-10 PHASE2
NCT01054573 COMPLETED
Hepatitis C, Chronic
Janssen Infectious Diseases BVBA
 2010-04 PHASE3
NCT01336829 COMPLETED
Hepatitis C; HIV
Tibotec Pharmaceuticals, Ireland
 2011-03 PHASE1
NCT01415141 WITHDRAWN
Hepatitis C
University of Vermont
 2011-07 PHASE4
NCT01275599 COMPLETED
Hepatitis C; Opioid-Related Disorders
Vertex Pharmaceuticals Incorporated
 2011-01 PHASE1
NCT00703118 COMPLETED
Hepatitis C, Chronic
Tibotec BVBA
 2008-10 PHASE3
NCT00758043 COMPLETED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2008-10 PHASE3
NCT00627926 COMPLETED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2008-03 PHASE3
NCT01038167 COMPLETED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2010-01 PHASE1
NCT00535847 COMPLETED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2007-10 PHASE2
NCT00903773 COMPLETED
Hepatitis C; Kidney Diseases
Tibotec BVBA
 2009-06 PHASE1
NCT00973388 COMPLETED
Hepatitis C
Tibotec BVBA
 2009-10 PHASE1
NCT00580801 COMPLETED
Hepatitis C
Tibotec BVBA
 2008-01 PHASE2
NCT00958152 COMPLETED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2009-08 PHASE1
NCT00933894 COMPLETED
Hepatitis C
Tibotec BVBA
 2009-09 PHASE1
NCT00933283 COMPLETED
Healthy Participants
Tibotec BVBA
 2009-07 PHASE1
NCT00528528 COMPLETED
Chronic Hepatitis C
Tibotec BVBA
 2007-10 PHASE2
NCT00828789 COMPLETED
Hepatitis C; HCV; HIV; AIDS
Tibotec BVBA
 2009-02 PHASE1
NCT00621296 COMPLETED
Hepatitis C
Tanabe Pharma Corporation
 2008-01 PHASE2
NCT00420784 COMPLETED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2007-02 PHASE2
NCT00775125 COMPLETED
Hepatitis C; Telaprevir; HIV
Tibotec BVBA
 2008-06 PHASE1
NCT00591214 COMPLETED
Chronic Hepatitis C
Tanabe Pharma Corporation
 2007-12 PHASE1
NCT00509210 COMPLETED
Hepatic Insufficiency
Vertex Pharmaceuticals Incorporated
 2007-09 PHASE1
NCT00561015 COMPLETED
Hepatitis C, Chronic
Tibotec BVBA
 2007-12 PHASE2
NCT00372385 COMPLETED
Chronic Hepatitis C
Vertex Pharmaceuticals Incorporated
 2006-08 PHASE2
NCT00336479 COMPLETED
Chronic Hepatitis C
Vertex Pharmaceuticals Incorporated
 2006-06 PHASE2
NCT01253551 COMPLETED
Hepatitis C
Tibotec BVBA
 2010-12 PHASE1
NCT00262483 COMPLETED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2005-12 PHASE2
NCT00251199 COMPLETED
Hepatitis C
Vertex Pharmaceuticals Incorporated
 2005-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2023-01-05)

Check the Telaprevir (VX-950) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Telaprevir binds to and potently inhibits the hepatitis C virus (HCV) NS3-4A serine protease, thereby preventing essential viral polyprotein processing and halting intracellular viral replication within hepatocytes. By suppressing viral maturation and viral load, this targeted mechanism forms the foundation for treating chronic hepatitis C virus infection evaluated across clinical trials.

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>).

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