Recent Updates
Recently added Catalysts

Paritaprevir/ritonavir/ombitasvir

Phase 3

Hepatitis C, Acute | Small molecule | Infectious Disease |AbbVie Inc.|Last Updated: Aug 22, 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment83

FDA Designations

No designations recorded

Clinical trial landscape

Paritaprevir/ritonavir/ombitasvir · 1 trial · 1 indication

Phase 3 1
NCT02634008Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/PHepatitis C, Acute
COMPLETED83 Analytics
PHASE3COMPLETED
Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P
Hepatitis C, Acute
NCT0263400883
Unlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of treated subjects (intention-to-treat (ITT) population) demonstrating undetectable hepatitis C virus (HCV) RNA at 12 weeks following treatment (SVR 12).
12 weeks post treatment

Secondary Endpoints

The proportion of treated subjects overall with ETR, SVR4 and SVR24 defined as undetectable HCV RNA at end of therapy, 4 weeks and 24 weeks post therapy, respectively.
End of treatment- week 6 or week 8 depending on the study arm; 4 weeks post treatment; 24 weeks post treatment
Comparison of ETR, SVR4, SVR12 and SVR24 between those receiving 8 weeks treatment and those receiving 6 weeks treatment.
End of treatment- week 6 or week 8 depending on the study arm; 4 weeks post treatment; 12 weeks post treatment; 24 weeks post treatment
Comparison of adherence between those receiving 8 weeks treatment and those receiving 6 weeks treatment
Baseline to week 6 or week 8 treatment duration
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALParitaprevir/ritonavir/ombitasvir (75mg/50mg/12.5mg) and dasabuvir (250mg) with or without ribavirin (1000-1200mg) daily taken orally for 8 weeks.
Cohort 2EXPERIMENTALThree tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 6 weeks
Cohort 3EXPERIMENTALThree tablets of glecaprevir/pibrentasvir (100mg/40mg) daily taken orally for 4 weeks

Interventions

NameTypeDescription
Paritaprevir/ritonavir/ombitasvirDRUG -
DasabuvirDRUG -
RibavirinDRUG -
Glecaprevir/pibrentasvirDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Provision of written informed consent; * Male and female patients aged 18 years and over; * For Cohort One: willing to use two effective methods of contraception during the treatment period and 24 weeks post; * For Cohort Two and Three: If female and of childbearing potential,...

Countries:AustraliaNew ZealandUnited Kingdom
Unlock Eligibility Criteria

Frequently asked questions about Paritaprevir/ritonavir/ombitasvir

What is Paritaprevir/ritonavir/ombitasvir used for?

Paritaprevir/ritonavir/ombitasvir is used for the treatment of acute Hepatitis C. It is a small molecule combination therapy being developed by AbbVie Inc. for this infectious disease indication. The drug is currently in Phase 3 clinical development.

What does Paritaprevir/ritonavir/ombitasvir target?

Paritaprevir/ritonavir/ombitasvir is a combination of direct-acting antiviral agents that target the Hepatitis C virus. It includes paritaprevir, a protease inhibitor, and ombitasvir, an NS5A inhibitor, with ritonavir as a pharmacokinetic booster. This combination works to inhibit viral replication.

Who makes Paritaprevir/ritonavir/ombitasvir?

Paritaprevir/ritonavir/ombitasvir is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate this drug for the treatment of acute Hepatitis C.

What phase is Paritaprevir/ritonavir/ombitasvir in?

Paritaprevir/ritonavir/ombitasvir is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of acute Hepatitis C. The Phase 3 trial has been completed, with results expected to inform further development.

What clinical trials is Paritaprevir/ritonavir/ombitasvir in?

Paritaprevir/ritonavir/ombitasvir has been studied in one completed Phase 3 clinical trial, identified as NCT02634008. This trial, titled 'Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P', enrolled 83 participants across Australia, New Zealand, and the United Kingdom.

Is Paritaprevir/ritonavir/ombitasvir the same as the 3D regimen?

Paritaprevir/ritonavir/ombitasvir is commonly referred to as the 3D regimen in clinical research. The combination of paritaprevir, ritonavir, and ombitasvir is known as the 3D regimen, which was evaluated in the Phase 3 trial NCT02634008 for the treatment of acute Hepatitis C.