Sponsor/Test Article

Upcoming Liver Unit Clinical Trials

Sponsor/Test Article / Type / Enrollment / Key Information /
VERTEX 114 – Phase 3b
Telaprevir +Peg+RBV for 12 vs 24 weeks in CC genotype
ANGIE / HCV
Geno 1
Naïve, Relapsers / Enrolling NOW
Need 5 patients
JUST ONE PATIENT PLEASE, PLEASE, PLEASE! / BMI > 35 excluded
Non-cirrhotic
All TVR med exclusions apply
HCV-TARGET
Observational data collection of all patients consenting to be observed during their SOC HCV treatment
JACOB / HCV
Any Genotype
Naïve or NR
All fibrosis stages
OLT ok / Enrolling NOW
Need 170+ patients / All patients undergoing HCV treatment in our clinics
Must be >18 years and able to consent
BMS-028 -- Phase 3
Open-Label Study with Asunaprevir and Daclatasvir for 24 weeks. One naïve cohort gets placebo x 12 weeks then rollover to open label study
AMY / Naïve
Null/Partial responders
1b / Naïve cohort enrolled
Need well documented Null/Partial Responders / HCV RNA 10,000
No hemophilia
No significant psych – many antidepressants prohibited
ASV (NS3 protease inhibitor)
DSV (NS5A)
Idenix
Open label IDX184 + Telaprevir + RBV for 12 weeks / HCV
Geno 1
Naïve or Relapser to PEG/RBV / DELAYED pending protocol amendment / BMI <36
NON-CIRRHOTIC
Plt >90
ABBOTT M11-646
Phase 3
ABT450/Ritonavir/ABT 267/ABT333/RBV / HCV
Naïve
Geno 1 / Anticipated start Jan 2013
Boehringer Ingelheim –Phase 3
Protease (BI 201335) + Polymerase (BI 207127) + RBV / HCV
Naïve
Geno 1a CC or 1b CC/CT/TT / 16 VS 24 weeks
Cirrhotics = open label for 24 weeks
Others 1:1 randomization of placebo for 8 weeks + open label for 16 weeks VS
Open label for 24 weeks / Weight 88-275 lbs
Plt >75
ANC >1000
HCV RNA > 1000
Compensated cirrhotics OK
Boehringer Ingelheim – Phase 3 / HCV
Naïve
Geno1b
Child A or B / Coming soon / mild/mod hepatic impairment
BAYER RAMPUP
Sorafenib dose escalation trial
ANGIE / HCC
Any patient eligible for but naïve to sorafenib
Childs A/B / Enrolling Now
Need 120 patients
84 patients enrolled / Prior systemic or locoregional therapy is accepted
Done largely as SOC with data shadowing
2 arms- one randomized to standard sorafenib dosing, the other randomized to a ramp up schedule beginning at 200mg QD

OTHER POTENTIAL TRIALS IN THE COMING MONTHS:

NASH

GENFIT: Double-blind, 3 arm, parallel group (placebo VS GFT505 80mg VS GFT 505 160mg QD X 52

weeks). BMI 45, Child A accepted, Must have liver biopsy within 6 months of screening

documenting steatohepatitis

HCC

BAYER: Regorafenib

Daiichi Sankyo + ArQule: Tivantinib (Phase 3)

CONTACT:

Angie Martin

352-273-9512

Amy Gunnett

352-273-9470

Updated 8/13/2012