Clinical Trial Search

Primary: Percentage of Participants With a Favorable Clinical Response at Completion of IV Study Therapy — 96.3; 98.8; 95.2 Percentage of participants — p=< 0.001

Primary: Number of Participants With Best Overall Response — 0; 3; 6 Participants

Primary: Annual Rate of Decline in Forced Vital Capacity (FVC) — -129.0; -137.5; -132.9 milliliters per year (mL/ yr)

Primary: Response Assessment — 0; 0; 0; 0 Participants

Primary: Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation — -12.4; -6.7 units on a scale

Primary: Reduction in Frequency of Defecation to 3 Times Per Day — 118; 24 Participants

Primary: Number of Women With Clinical Cure as a Measure of Efficacy — 7; 12; 7; 3 Participants — p=0.006

Primary: Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse…

Primary: Number of Participants With Overall Success — 36; 17 Participants

Primary: Safety as Measured by Number of Participants With Treatment-related Grade 3 or 4 Local and Systemic Toxicity as Defined by NCI CTCAE v3.0 — 3; 2; 4 Participants

Primary: Objective Response Rate (ORR) — 16 Participants

Primary: Dose Limiting Toxicity (Phase I) — 0; 0; 0; 0 Participants

Primary: Delta SOFA Score — -1.8; -0.34; -1.68; -2.15 units on a scale

Primary: Number of Participants With Treatment-Emergent Adverse Events — 14; 7; 7; 4 Participants

Primary: Mean Change in Serum HBsAg From Baseline to Week 24 — -0.079; -0.096; -0.016; -0.135 log10 IU/mL — p=0.805