Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Grazoprevir/ Elbasvir · 1 trial · 1 indication
Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR12 was defined as HCV RNA \<Lower Limit of Quantification (\<15 IU/mL) 12 weeks after the end of all study therapy.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
| Arm | Type | Description |
|---|---|---|
| Immediate Treatment Group | EXPERIMENTAL | Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period |
| Deferred Treatment Group | PLACEBO_COMPARATOR | Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was continued for an additional 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Grazoprevir 100mg / Elbasvir 50 mg FDC | DRUG | - |
| Placebo to Grazoprevir / Elbasvir 50 mg FDC | DRUG | - |
Inclusion criteria: * Documented chronic HCV GT1, GT4, or GT6 with no evidence of non-typeable or mixed genotype infection (positive for anti-HCV antibody, HCV RNA, or any of the listed GTs at least 6 months prior to screening must be confirmed by screening lab results) * Cirrhosis defined by: live...
Grazoprevir is an investigational small molecule being developed for the treatment of Hepatitis C Virus infection, including chronic Hepatitis C. It is being studied in combination with other antiviral agents such as elbasvir and with peginterferon and ribavirin. The drug is currently in Phase 2 clinical development.
Grazoprevir is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with chronic Hepatitis C infection.
Grazoprevir is currently in Phase 2 clinical development. It has completed 13 clinical trials with a total enrollment of 2,989 participants. The drug is investigational and has not been approved by regulatory authorities for any indication.
Grazoprevir has been studied in several completed clinical trials, including NCT01353911, which evaluated the drug with peginterferon and ribavirin in treatment-naïve patients with chronic Hepatitis C. Other trials include NCT01710501, NCT01937975, and NCT02105467, which studied different dosing regimens and combinations.
Yes, Grazoprevir is also known as MK-5172. Clinical trial records refer to the drug by both names, such as in the study titled 'Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C.'