HSC Clinical Trials:

• Critical Care
• Neurosurgery
• Pediatrics
• Psychiatry/Behavioral Medicine
• Surgery

Critical Care

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Recombinant Erythropoietin (Epoetin alfa; PROCRIT) on Functional Outcomes in Anemic, Critically Ill Trauma Subjects (PROCRIT Blunt Trauma)

Objectives

The primary objective of this study is to evaluate the physical function outcomes in anemic, critically ill, trauma subjects treated with PROCRIT® (epoetin alfa) compared to placebo. This study also seeks to evaluate functional independence, Health Related Quality of Life (HRQL), time to Hemoglobin (Hb) response, Hb change over time, return to usual activities, neurocognitive function, and time on mechanical ventilation.

Eligibility

1. Male or female.
2. Age between 18 and 55 years, inclusive. Age >55 may qualify for study entry but each case must be discussed with the Medical Monitor.
3. Hemoglobin = 12 g/dL within 24 hours of study entry (Baseline/Study Day 1).
4. An expected ICU stay = 2 days.
5. ICU admission secondary to a blunt multi-system traumatic injury sustained on this hospital admission.
6. A lower extremity long bone or pelvic fracture must be one of the injuries sustained.
7. Glascow Coma Scale (GCS) score must be = 13 at hospital admission or within 24 hours of admission.
8. Documented ability to function independently prior to this hospitalization as determined by a subject or proxy interview using the Karnofsky Performance scale; subjects must achieve a score greater than or equal to 80 to be eligible for study entry.
9. Subjects (or appropriate legal representative) must sign the informed consent form after the nature of the study has been fully explained.
10. Female subjects with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during study
11. Subjects must be literate in their native language in order to complete written self-assessments during the post-hospital discharge phase.
12. Body Mass Index(BMI)<40kg/m2.

For more information about this trial, please contact the Study Coordinator.

Contacts

Lawrence Roberts, MD, Principal Investigator
(304) 598-4659, robertslaw@rcbhsc.wvu.edu

Tammy Clark , Study Coordinator
(304) 293-5264, tclark@hsc.wvu.edu

Sue Collins , Study Coordinator
(304) 293-7348, scollins@hsc.wvu.edu

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Neurosurgery

A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCel Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery.

Objectives

The objective of this study is to test that SyntheCel Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the the cranial dura.

Eligibility

Patients are included in the study if all of the following criteria are met:

1. Patient is between 18 and 75 years of age.
2. Patient is scheduled for an elective cranial procedure requiring a dural incision.
3. Patient has an MRI no earlier than two months prior to the date of enrollment.
4. Surgical wound is expected to be Class I/clean.
5. Patient is available and willing to participate in the investigation for the duration of the study.
6. Patient has signed a written Informed Consent to participate in the study prior to any study mandated determinations or procedures. This does not include MRIs that may be performed prior to obtaining informed consent.

For more information about this trial, please contact the Study Coordinator.

Contacts

Julian E. Bailes, Jr., MD, Principal Investigator
(304) 293-5041, jbailes@hsc.wvu.edu

Sue Collins , Study Coordinator
(304) 293-7348, scollins@hsc.wvu.edu

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Pediatrics

A Randomized, Open Label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder (TIP) Compared to TOBI in Cystic Fibrosis (CF) Subjects.

Objectives

1. The primary objective is to evaluate the safety in cystic fibrosis (CF) subjects of a twice-daily (BID) dosing regimen of Tobramycin Inhalation Powder (TIP) delivered by the T-326 Inhaler as compared to TOBI* delivered with the PARI LC PLUS™ Jet Nebulizer and DeVilbiss PulmoAide™ compressor or a suitable alternative. Suitable compressors are those that, when attached to a PARI LC PLUS nebulizer, deliver a flow rate of 4 to 6 L/min and/or back pressure of 110 to 217 kPa.
2. The secondary objectives are: (a) to assess the efficacy of TIP as compared to TOBI, as measured by the relative change in forced expiratory volume at 1 second (FEV1 % predicted) from baseline to the end of cycle 3 dosing; and (b) to assess subject-reported treatment satisfaction by administering the Treatment Satisfaction Questionnaire for Medication (TSQM©).

Eligibility

1. Confirmed diagnosis of cystic fibrosis by documented sweat chloride 60 mEq/L or greater by quantitative pilocarpine iontophoresis test (QPIT) or homozygosity for F508 genetic mutation (or heterozygosity for two well-characterized mutations) and two clinical findings consistent with CF.
2. Male and female subjects ≥ 6 years of age at the time of screening.
3. FEV1 at screening must be ≥ 25% and ≤ 75% of normal predicted values for age, sex, and height based on Knudson criteria.
4. P aeruginosa must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit.
5. Able to comply with all protocol requirements.
6. Clinically stable in the opinion of the investigator.
7. Use of an effective means of contraception in females of childbearing potential.
8. Provide written informed consent, HIPAA authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure.

For more information about this trial, please contact the Study Coordinator.

Contacts

Kathryn S. Moffett, MD, Principal Investigator
(304) 293-1217, kmoffett@hsc.wvu.edu

Sue Collins, Study Coordinator
(304) 293-7348, scollins@hsc.wvu.edu

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Pediatrics
 Multi-Center, Multi-National, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects with Cystic Fibrosis 6-18 years old, Culture Negative for Pseudomonas aeruginosa (AZ0004)

Objectives
Primary Objective
The primary purpose of this study is to determine effect of 24 weeks of three times weekly administration of azithromycin as compared to placebo on pulmonary function in CF subjects who are culture negative for P. aeruginos.
Secondary Objectives
Secondary objectives are to determine the safety of 24 weeks of three times weekly administration of azithromycin as compared to placebo, to determine the effect of 24 weeks of three times weekly administration of azithromycin as compared to placebo on exacerbation parameters, weight, height, microbiology, and inflammatory markers, and during the 24 week open label, follow-on study, to determine the long term safety, tolerability, and durability of response to azithromycin among subjects continuing on azithromycin after the randomized portion of the trial and among placebo subjects switching over to azithromycin after the randomized trial.

Eligibility

1. Male and female 6-18 years of age at enrollment.
2. Confirmed diagnosis of cystic fibrosis by one or more clinical features consistent with the CF phenotype and documented sweat chloride >60 mEq/L (by pilocarpine iontophoresis test), or a genotype with tow identifiable mutations consistent with CF.
3. Provide written informed consent, HIPAA authorization (where applicable), and
4. assent (as appropriate) prior to the performance of any study-related procedure.
5. Clinically stable at enrollment as assessed by the site investigator.
6. Respiratory cultures negative for P aeruginosa for one year or longer at the time of screening as defined as at least two consecutive respiratory cultures negative for P aeruginosa which could include the negative screening culture as one of the two consecutive cultures. (Respiratory culture can be sputum, bronchial wash, or oropharyngeal swab for non-sputum producers).
7. FEV1 predicted ≥ 50% as calculated by the Wang reference equations (refer to study manual)
8. Able to comply with all protocol requirements.
9. Ability to swallow a 250mg tablet.

For more information about this trial, please contact the Study Coordinator.

Contacts
Kathryn S. Moffett, MD, Principal Investigator
(304) 293-1217, kmoffett@hsc.wvu.edu

Sue Collins, Study Coordinator
(304) 293-7348, scollins@hsc.wvu.edu

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Surgery

Phase 3b, Open-Label, Single-Group Immunogenicity and Safety Study of Topical Recombinant Thrombin (rThrombin) in Surgical Hemostasis (rThrombin)

Objectives

The primary objective of this study is to compare the development of anti-rThrombin product antibodies at Day 29 between subjects with and without baseline anti-bovine thrombin product antibodies. 
Secondary objectives are to further define the safety profile of rThrombin and to evaluate safety outcomes in subjects with and without baseline anti‑bovine thrombin product antibodies. 

Eligibility

1.         Are undergoing one of the following surgeries:

• Spinal surgery:  cervical, thoracic, or lumbar discectomy; corpectomy, laminectomy, lateral or interbody fusion, including both anterior and posterior approaches (does not include minimally invasive procedures, e.g., microdiscectomy)
• Arterial reconstruction (e.g., patching), peripheral arterial bypass, or arteriovenous (AV) vascular access procedures

2.         Have a history of prior surgery with high likelihood of bovine thrombin exposure within the last 3 years.  The prior surgery must have been one of the following open (e.g., not endoscopic or endovascular) procedures:

• Open procedures involving the spine or cranium
• Peripheral arterial bypass
• AV vascular access procedures
• Arterial reconstruction
• Autologous skin grafting
• Other surgical procedure for which subject’s prior treatment with bovine thrombin was documented

3.         Are ≥18 years of age at time of informed consent
4.         Have a negative pregnancy test within 14 days prior to treatment, if female and of child-bearing potential
5.         Agree to use a medically accepted form of contraception from the time of informed consent to completion of all follow-up study visits, if the subject is a sexually active male or a sexually active female of childbearing potential
6.         Have signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document

For more information about this trial, please contact the Study Coordinator.

Contacts
Lakshmikumar Pillai, MD, Principal Investigator
(304) 293-2367, lpillai@hsc.wvu.edu

Tammy Clark, Study Coordinator
(304) 293-5264, tclark@hsc.wvu.edu

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Surgery

Carotid Stenting for HIgh Surgical Risk Patients; Evaluating Outcomes Through the Collection of Clinical Evidence (CHOICE)

Objectives
To provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under commercial use conditions.

To provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients.
Eligibility

1. Patient or patient’s legally authorized representative provided informed consent.
2. Patient is considered at high risk for carotid endarterectomy (CEA).
3. Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
4. Patient’s physician intends to use an RX Acculink with the RX Accunet in the carotid artery or an Xact with the Emboshield in the carotid artery as per the FDA approved Indications for Use as outlined below:

• Patients with neurological symptoms and ≥ 50% stenosis of the common or internal carotid artery by ultrasound or angiogram,

            OR

• Patients without neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiogram.

For more information about this trial, please contact the Study Coordinator.

Contacts
Lakshmikumar Pillai, MD, Principal Investigator
(304) 293-2367, lpillai@hsc.wvu.edu

Tammy Clark, Study Coordinator
(304) 293-5264, tclark@hsc.wvu.edu

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Surgery

A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI) (MNTX3301)

Objectives

The primary objective of this study is to test the following hypothesis: In patients who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.

Secondary objectives are:

1. To assess the safety of IV MNTX administered every six hours in these post-surgical patients.
2. To assess the effects of IV MNTX on time to discharge eligibility and time to hospital discharge.
3. To examine frequency and bothersomeness of nausea and vomiting as assessed by the SDS instrument.

Eligibility

1. Male and female patients = 18 years of age
2. Patients must meet the American Society of Anesthesiologists (ASA) physical status I, II, or III.
3. Patients must be scheduled for a segmental colectomy via open laparotomy with general anesthesia. Acceptable procedures include: partial colectomy, colectomy (right or left), transverse colectomy, hemicolectomy (right or left), sigmoidectomy, cecectomy, anterior prctosigmoidectomy, and low anterior protocsigmoidectomy. All patients must have primary anastomosis.
4. Patients with a history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met.
5. Negative for history of chronic active hepatitis B, HCV or HIV infection.
6. Patients must sign an ICF.
7. Females of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test prior to surgery and must use appropriate forms of birth control (oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device or IUD), throughout the study.
8. Body weight within range of 40 kg - 150 kg (88 - 330 lbs.)

For more information about this trial, please contact the Study Coordinator.

Contacts

Riaz Cassim, MD, Principal Investigator
(304) 293-2706, rcassim@hsc.wvu.edu

Tammy Clark , Study Coordinator
(304) 293-5264, tclark@hsc.wvu.edu

Sue Collins , Study Coordinator
(304) 293-7348, scollins@hsc.wvu.edu

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