An Open-Label Study of Two Different Doses of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution When Used as an Aid for Ureteral Patency
Phase: PHASE3
Conditions: Ureter Injury
Sponsor: Prove pharm

Protocol PVP-19IC01 Clarification Letter #2, dated 18 Dec 2020 
Page 1 of 2 
To:   PVP-19IC01 Principal Investigators  
From:  Provepharm PVP-19IC01 Study Team 
RE: 
Removal of Pharmacokinetic sub study from protocol PVP-19IC01 amendment #2: 
An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, 
Pharmacokinetics and Physician Satisfaction of Two Different Doses of 3,3'-Dioxo-2,2'-
bisindolylidene-5,5'-disulfonate disodium 0.8% Solution When Used as an Aid in the 
Determination of Ureteral Patency. 
This Clarification Letter is to remove the pharmacokinetic (PK) sub-study from the PVP-19IC01 
protocol, Amendment # 2 dated 02 September 2020.  
This protocol specifies that PK samples of plasma, urine and stool will be collected from a subset 
of approximately 16 subjects from 2 participating PK sites. 
Zero patients have been enrolled into the PK sub study due to the difficulty in recruiting patients 
for the clinical trial during the COVID-19 emergency.   Additionally, the logistical complexity 
involved with conducting the PK portion has made it challenging for the 2 sites to recruit 
consenting subjects.  Therefore, the recruitment of patients for the PK sub study of the trial will 
be discontinued.  A separate PK study will be conducted to obtain the necessary PK data.  
Additionally, it was noted that the header of the approved protocol amendment 2, starting at page 
19 through the end of the protocol, references the year 2019.  The correct year should be 2020. 
Please sign and date in the acknowledgment section below, return a copy of the signed document 
to Provepharm, Inc. and file the original in the current protocol section of your investigational 
site file. 
NCT#: 04228445

Protocol PVP-19IC01 Clarification Letter #2, dated 18 Dec 2020 
Page 2 of 2 
Approvals: 
Sponsor 
 
Director, Clinical Operations 
Signature and Date 
Medical Monitor 
 
 
Signature and Date 
Acknowledged: 
Principal Investigator: 
Printed Name 
Signature and Date