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View 0 Studies Requested

A phase I single-arm, multicenter pilot study aimed at validating γ-OHPdG as a biomarker and testing the effects of Polyphenon E® on its levels in patients with cirrhosis

Enrollment Statistics

Underwent Pre-enrollment: 46

  • Eligible: 14

    • 400mg QD: 3

      • Study Complete: 3

    • 400mg BID: 3

      • Protocol Defined Follow-up Completed: 2

      • Study Completed: 1

    • 600mg BID: 3

      • Participant Refused Follow-Up: 1

      • Study Complete: 2

    • 800mg BID: 4

      • Adverse Event: 2

      • Study Complete: 2
    • Not given treatment: 1

      • Lost to follow-up: 1

  • Other: 20

    • Lost to follow-up: 2

    • Other, specify: 2

    • Participant Withdrawal: 6

    • Physician Decision: 2

    • Ineligible: 20

Total Study Population Demographics (13 Eligible People):

Treatment Dose
Overall,
N = 13
DC 1: 400mg once a day,
N = 3
DC 2: 400mg two times a day,
N = 3
DC 3: 600mg two times a day,
N = 3
DC 4: 800mg two times a day,
N = 4
Age at registration in years, median (IQR) 63 (59-68) 59 (58-68) 63 (63-64) 63 (59-67) 67 (61-69)
Gender, N (%)
Male 5 (38%) 1 (33%) 2 (67%) 0 2 (50%)
Female 8 (62%) 2 (67%) 1 (33%) 3 (100%) 2 (50%)
Ethnicity, N (%)
Hispanic or Latino 6 (46%) 1 (33%) 1 (33%) 2 (67%) 2 (50%)
Not Hispanic or Latino 7 (54%) 2 (67%) 2 (67%) 1 (33%) 2 (50%)
Race, N (%)
Black or African American 5 (38%) 2 (67%) 0 2 (67%) 1 (25%)
White 8 (62%) 1 (33%) 3 (100%) 1 (33%) 3 (75%)