Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Grazoprevir+ Elbasvir · 1 trial · 1 indication
HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Grazoprevir + Elbasvir 12 weeks | EXPERIMENTAL | Participants receive grazoprevir 100 mg/elbasvir 50 mg fixed-dose combination (FDC) tablets once daily (q.d.) by mouth for 12 weeks. |
| Grazoprevir + Elbasvir + RBV 12 weeks | EXPERIMENTAL | Participants receive grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules twice daily (b.i.d.) by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks. |
| Grazoprevir + Elbasvir 16 weeks | EXPERIMENTAL | Participants receive grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks. |
| Grazoprevir + Elbasvir + RBV 16 weeks | EXPERIMENTAL | Participants receive grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| Grazoprevir + Elbasvir | DRUG | FDC tablet containing grazoprevir 100 mg and elbasvir 50 mg. |
| Ribavirin | DRUG | 200 mg capsule |
Inclusion Criteria: * Documented chronic HCV GT1, GT4, or GT6 with no evidence of non-typable or mixed genotype infection (positive for anti-HCV antibody, HCV ribonucleic acid \[RNA\], or any of the listed GTs at least 6 months prior to screening must be confirmed by screening lab results) * Cirrho...
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.'