BridgeMD
A randomized, placebo-controlled, double-blind, multi-center trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with symptomatic polycystic liver disease
EU CTIS ID: 2023-505313-24-00
What this study is testing
To evaluate the treatment effect of CAM2029 compared to placebo on liver volume in patients with polycystic liver disease (PLD).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Voluntary and valid written informed consent to participate in the trial provided by the patient before any trial related procedures are performed
- Male or female patient, ≥18 years at screening
- Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) with htTLV ≥1800 mL/m at screening
- Presence of at least 1 of the following PLD-related symptoms within 2 weeks before screening: bloating, fullness in abdomen, lack of appetite, feeling full quickly after beginning to eat, acid reflux, nausea, rib cage pain or pressure, pain in side, abdominal pain, back pain, shortness of breath after physical exertion, limited in mobility, concern about abdomen getting larger, dissatisfied by the size of abdomen
- Not a candidate for, or not willing to undergo, surgical intervention for hepatic cysts during the trial
- Female patients of childbearing potential must be willing to use an acceptable method of contraception from screening and during the entire trial
You likely can't join if
- Surgical intervention for PLD within 3 months before screening. For sclerotherapy patients, at least 6 months before screening
- Patients with a known history of hypothyroidism, unless they have been on adequate and stable replacement thyroid hormone therapy for at least 3 months before the first dose of the IMP.
- Uncontrolled hypertension defined by a systolic blood pressure of >160 mmHg and/or diastolic blood pressure of >100 mmHg at screening
- History of significant cardiac disease or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the trial, such as uncontrolled or significant cardiac disease, including any of the following: a. History of myocardial infarction, angina pectoris or coronary artery bypass graft within 6 months before screening b. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block or high-grade atrioventricular block (e.g. bifascicular block, Mobitz type II and third-degree atrioventricular block) c. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: i. Risk factors for Torsades de Pointes including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant/symptomatic bradycardia ii. Treatment with concomitant medication(s) with a "Known risk of Torsades de Pointes" per www.crediblemeds.org that cannot be discontinued or replaced by safe alternative medication at least 5 half-lives or 7 days (whichever is longer) before the first dose of IMP iii. Patients with a baseline QTc interval corrected by Fridericia's formula (QTcF) >450 msec for males and >470 msec for females at screening
- Patients with vascular compromise, including, but not limited to, mesenteric thrombosis, portal hypertension and thrombocytopenia (platelet counts less than 100x109/L)
- Pregnant, lactating or planning to be pregnant during the trial
See the full eligibility criteria
Who can join
- Voluntary and valid written informed consent to participate in the trial provided by the patient before any trial related procedures are performed
- Male or female patient, ≥18 years at screening
- Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) with htTLV ≥1800 mL/m at screening
- Presence of at least 1 of the following PLD-related symptoms within 2 weeks before screening: bloating, fullness in abdomen, lack of appetite, feeling full quickly after beginning to eat, acid reflux, nausea, rib cage pain or pressure, pain in side, abdominal pain, back pain, shortness of breath after physical exertion, limited in mobility, concern about abdomen getting larger, dissatisfied by the size of abdomen
- Not a candidate for, or not willing to undergo, surgical intervention for hepatic cysts during the trial
- Female patients of childbearing potential must be willing to use an acceptable method of contraception from screening and during the entire trial
- Male patients must be willing to use condom as method of contraception from screening and throughout the trial unless they have been sterilized by vasectomy (with an appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)
What rules you out
- Surgical intervention for PLD within 3 months before screening. For sclerotherapy patients, at least 6 months before screening
- Patients with a known history of hypothyroidism, unless they have been on adequate and stable replacement thyroid hormone therapy for at least 3 months before the first dose of the IMP.
- Uncontrolled hypertension defined by a systolic blood pressure of >160 mmHg and/or diastolic blood pressure of >100 mmHg at screening
- History of significant cardiac disease or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the trial, such as uncontrolled or significant cardiac disease, including any of the following: a. History of myocardial infarction, angina pectoris or coronary artery bypass graft within 6 months before screening b. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block or high-grade atrioventricular block (e.g. bifascicular block, Mobitz type II and third-degree atrioventricular block) c. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: i. Risk factors for Torsades de Pointes including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant/symptomatic bradycardia ii. Treatment with concomitant medication(s) with a "Known risk of Torsades de Pointes" per www.crediblemeds.org that cannot be discontinued or replaced by safe alternative medication at least 5 half-lives or 7 days (whichever is longer) before the first dose of IMP iii. Patients with a baseline QTc interval corrected by Fridericia's formula (QTcF) >450 msec for males and >470 msec for females at screening
- Patients with vascular compromise, including, but not limited to, mesenteric thrombosis, portal hypertension and thrombocytopenia (platelet counts less than 100x109/L)
- Pregnant, lactating or planning to be pregnant during the trial
- Clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the patient from safely participating in the trial
- History of solid organ transplantation. Exception for kidney transplant patients
- Any known allergy, hypersensitivity or intolerance to octreotide or any related drug, or other components of CAM2029, or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the patient
- Contraindications to, or interference with, MRI assessments, as dictated by local hospital regulations
- Previously treated/randomized in the current clinical trial
- Treatment with an Somatostatin analogue (SSA) within 3 months before screening
- Participation in any other clinical trial to test an investigational drug or device within the last 30 days before screening or during the trial
- Any other contraindicated serious medical condition that, in the Investigator’s opinion, may prevent the patient from safely participating in the trial
- Any other current or prior medical condition that may interfere with the conduct of the trial or the evaluation of its results in the opinion of the Investigator
- Unwilling or unable to comply with the requirements of the protocol or in a situation or condition that, in the opinion of the Investigator, may interfere with participation in the trial
- On the staff, affiliated with, or a family member of the personnel directly involved with this trial
- Non-responsive to previous treatment of PLD with an SSA as per the Investigator’s assessment
- Symptomatic cholelithiasis within 3 months before screening or previous medical history of cholelithiasis induced by SSAs unless treated with cholecystectomy
- Presence of extrahepatic cysts that, in the Investigator’s opinion, may prevent the patient from safely participating in the trial
- Severe kidney disease, as defined by estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2
- Severe liver disease defined as liver cirrhosis of Child-Pugh class C
- Use of oral estrogen contraceptives or supplementation within 3 months before screening
- Poorly controlled diabetes (hemoglobin A1c ≥10%) at screening
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.