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VX-135

Phase 2

Chronic Hepatitis C | Small molecule | Infectious Disease |Vertex Pharmaceuticals Incorporated|Last Updated: Dec 18, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials3
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

VX-135 · 3 trials · 4 indications

Phase 2 3
NCT01790100A Phase 2a, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis CChronic Hepatitis C
COMPLETED20 Analytics
NCT01842451A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis CChronic Hepatitis C
COMPLETED23 Analytics
NCT01726946A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis CChronic Hepatitis C
COMPLETED10 Analytics
PHASE2COMPLETED
A Phase 2a, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
Chronic Hepatitis CUnlock trial analytics
PHASE2COMPLETED
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
Chronic Hepatitis CUnlock trial analytics
PHASE2COMPLETED
A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
Chronic Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety
Week 12

The safety and tolerability as assessed by evaluating adverse events and laboratory testing.

The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments
Up to 64 weeks
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments
Up to 52 weeks

Secondary Endpoints

evidence of HCV RNA viral load reduction
16 weeks
The proportion of subjects who have a sustained virologic response (SVR; i.e., HCV RNA concentration below the lower limit of quantitation [<LLOQ; <25 IU/mL]) at 4 weeks after the last planned dose of treatment (SVR4)
Up to 20 Weeks
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Up to 28 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VX-135 low dose in combination with ribavirinEXPERIMENTAL12 weeks of VX-135 in combination with ribavirin
VX-135 high dose in combination with ribavirinEXPERIMENTAL -
VX-135 High Dose with DaclatasvirEXPERIMENTAL12 weeks of a high dose of VX-135 in combination with Daclatasvir
VX-135 Low Dose with DaclatasvirEXPERIMENTAL12 weeks of a low dose of VX-135 in combination with Daclatasvir
VX-135 High Dose with ribavirinEXPERIMENTAL12 weeks of a high dose of VX-135 in combination with ribavirin
VX-135 Low Dose with ribavirinEXPERIMENTAL12 weeks of a low dose of VX-135 in combination with ribavirin

Interventions

NameTypeDescription
VX-135DRUG12 weeks of VX-135
RibavirinDRUG12 weeks of ribavirin
DaclatasvirDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * Subjects (male and female) must be between 18-60 years of age * Subjects must have Chronic Hepatitis C * Subjects must be treatment naive * Subjects must have laboratory values at screening within limits as specified by the protocol Key Exclusion Criteria: * Evidence of ...

Countries:MoldovaNew ZealandUnited States
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Frequently asked questions about VX-135

What is VX-135 used for?

VX-135 is an investigational small molecule being developed for the treatment of chronic hepatitis C, a viral infection of the liver. It has been studied in Phase 2 clinical trials in patients with chronic hepatitis C, including those with genotype 1 infection.

Who makes VX-135?

VX-135 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company has conducted multiple clinical trials of VX-135 in patients with chronic hepatitis C.

What phase is VX-135 in?

VX-135 is in Phase 2 clinical development. It has completed three Phase 2 clinical trials, which were randomized, double-blind, and controlled. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is VX-135 in?

VX-135 has been studied in three completed Phase 2 clinical trials. These include NCT01726946, a study of VX-135 with ribavirin in treatment-naive patients; NCT01790100, a dose-ranging study with ribavirin; and NCT01842451, a study of VX-135 with daclatasvir in genotype 1 chronic hepatitis C.

How does VX-135 work?

VX-135 is a small molecule drug that targets the hepatitis C virus. It is designed to interfere with viral replication, helping to clear the infection from the body. The drug has been studied in combination with other antiviral agents such as ribavirin and daclatasvir.