Part A: RG7388 as a single agent; given at a starting dose of 100 mg each day for five days for the first cycle which will be 56 days.
Part B: combination of RG7388 and Pegasys if subject does not achieve at least a PR by the end of 3 cycles of single agent RG7388

Polycythemia Vera

Essential Thrombocythemia

RG7388 is supplied as film-coated tablets at dosage strengths of 50 mg, 200 mg, 300mg and 400 mg.

RG7388

PEGASYS is supplied as a clear, sterile solution for subcutaneous (SQ) injection available in prefilled syringes. weekly doses at 45ug subcutaneously

Pegasys

Georgetown University Medical Center

Icahn School of Medicine at Mount Sinai

Wake Forest University Baptist Medical Center

Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia

Open Label Phase I Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia (With Pilot Feasibility Study in Combination With Pegylated Interferon Alfa 2a for Patients Who do Not Respond to the Single Agent at Each Dose Level)

John Mascarenhas

Associate Professor

Roche Pharma AG

The Leukemia and Lymphoma Society

No manipulative intervention. Phlebotomy for inflammatory biomarker determinations to compare acute versus chronic at baseline.

Inflammatory biomarker determinations after a course of 6 SMT interventions over the period of 2 weeks; a single SMT per treatment.

Asymptomatic subjects. Biomarker determinations at time zero and again two weeks later.

Low Back Pain

Spinal manipulation will consist of a single high velocity low amplitude thrust to a hypomobile vertebral segment determined by the treating clinician to contribute to the problem.

Spinal manipulation

Outpatient clinics, Canadian Memorial Chiropractic College

Effects of Spinal Manipulative Treatment on Inflammatory Markers in Low Back Pain Patients

Changes in Inflammatory Cytokine Levels in Response to Spinal Manipulative Treatment of Low Back Patients: A Single-blind Pilot Clinical Trial.

Supernatants from whole blood cultures are collected 24 or 48 hours postincubation, are dispensed in 0.5-1.0 ml aliquots and stored at 76C. Because subject recruitment occurs over a long period,it is not desirable to process samples sporadically. This approach allows using same-batch reagents/bioassay kits for all samples in an effort to decrease error and enhance internal consistency. Results will be expressed as the difference between the values obtained for acute, chronic and control at baseline.

Postintervention samples (whole blood culture supernatants) will be aliquoted and stored at -76C. proinflammatory cytokine levels will be compared to their respective baselines as well as the asymptomatic controls. These samples will be processed along with those for the primary outcome measure. Results will be expressed as the difference between baseline and endpoint (i.e. end of two week treatment period).

Parallel bioassays will be done on samples from the same culture supernatants in order to determine the levels of antiinflammatory mediators and chemokines. Changes in the levels of these mediators in response to manipulative treatment may be correlated to changes in proinflammatory mediator levels. Results will be calculated as the difference between baseline and endpoint (i.e. end of two week treatment period).

sciatica/главоболка

Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia

Effects of Spinal Manipulative Treatment on Inflammatory Markers in Low Back Pain Patients

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