Hi foo... Happy New Year!
Looks like you are getting some good results so far. Hang in there and keep the prize in your sights. I have not yet received my 4 week PCR, I do have all the other labs for week 4. You brought up some good questions about the different arms and duration, I scanned the trial docs in and did a copy/paste, thought we could use this for a quick reference if needed. If there are some grammer errors it's from the OCR. This is for the naive study only.
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How Long Will This Study Last?
The screening phase to determine whether you qualify for the study should take approximately 1 to 8 weeks. The study will include 28 or 48 weeks of therapy. The length of the study phase will be based on the study arm to which you will be assigned. The follow-up phase will, also depend on the study arm to which you are assigned, and will range from 24 weeks to 44 weeks. In total, you will be participating in the study for 72 weeks once you are randomly assigned to the study.
Study Procedures
All arms initially will start with “Lead-in”. The lead-in period will be therapy with only Peglntron and ribavirin for 4 weeks. Peglntron (1.5 mcg/kg) will be injected subcutaneously (under the skin) weekly and ribavirin (600 to 1400 mg/day, based on your weight) will be taken by mouth 2 times a day.
After the “lead in” period, the drugs you receive will depend on which arm of this study you are randomly assigned to and how the virus in your blood responds to the drugs.
How will the assignment be done?
Assignment to a study arm will be determined by chance like a toss of a coin. You will have a 2 out of 3 chance to receive the experimental drug boceprevir plus standard treatment with Peglntron and ribavirin, and a 1 out of 3 chance to receive standard treatment with Peglntron and ribavirin alone. The study subjects who receive Peglntron and ribavirin alone, will also receive a placebo, which by appearance looks like boceprevir, but doesn’t have any active medical ingredient. The study assignment will be done by a computerized system, called the Interactive Voice Response System (IVRS), in a “double blind” fashion. This means that neither you nor your study doctor will know which arm you are in and what drug regimen you will receive. The dose of your Peglntron and ribavirin will be based on your weight when you enter the study. The study procedures for each of the arms is described below:
Arm 1: Subjects in this arm will receive Peglntron 1.5 mcg/kg and ribavirin, along with placebo. The arm is called the “control” arm.
• Lead-in phase: Peglntron + ribavirin for 4 weeks (see above)
• After week 4 (TW4), you will be given a placebo pill. This will be taken by mouth 3 times a day, in addition to your Peglntron and ribavirin therapy.
• You may continue with placebo, Peglntron and ribavirin for up to 44 weeks.
• At TW 24, the amount of virus in your blood will be measured to determine whether or not you will be able to continue the study after week 28:
- If the hepatitis C virus is not detectable (no hepatitis C virus measured in your blood), you will continue with placebo + Peglntron and ribavirin therapy for a total of 48 weeks.
- If the hepatitis C virus is detectable after 24 weeks, you will be discontinued from the study at TW 28. If you are discontinued from this control arm, you will have two options. You can either proceed to follow-up, where you will no longer be receiving the study drug but will be monitored for side effects, or since you were in the control arm, you can choose to participate in another boceprevir study called “PROVIDE” (where you will be given boceprevir as well as your Peglntron and ribavirin treatment). While you are receiving the study drug, the study doctor and staff will not know you are in the control arm. If your virus is detected after week 24 and the study drug is stopped, the study doctor and staff will be informed by SPRI whether or not you are might qualify for the PROVIDE study. Your study doctor will discuss these options with you in detail during your discontinuation visit.
Arm 2: Subjects in this arm will receive a short period (24 weeks) of boceprevir plus Peglntron 1.5 mcg/kg and ribavirin and possibly an additional 20-week with Peglntron and ribavirin, along with boceprevir placebo, depending on how fast they respond to therapy.
• Lead-in phase: Peglntron + ribavirin for 4 weeks.
• After TW 4, boceprevir (800 mg by mouth, 3 times a day), will be added to the Peglntron + ribavirin.
• At TW 8, the amount of hepatitis C virus in your blood will be measured to determine whether or not, you will be continuing the study after week 28:
-If the hepatitis C virus is not detectable in your blood at TW 8 and at all subsequent visits, then at TW 28 you will discontinue active study therapy, and proceed to 44 weeks of follow-up.
-If the hepatitis C virus is detectable in your blood at TW 8 or at any subsequent visit, t hen at TW 28 the boceprevir will be switched to a placebo pill (neither you nor your study doctor will know this has occurred), and you will continue, to take placebo + Peglntron + ribavirin for an additional 20 weeks (for a total duration of 48 weeks) followed by 24 week follow-up.
• At TW 24 the amount of virus, in your blood will be measured to determine whether or not you will be continuing the study therapy:
-If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned therapy.
-If the hepatitis C virus is detected in your blood after 24 weeks, you will be discontinued from the active study. For that reason you might be asked to come to the clinic for an unscheduled visit for a test of the amount of hepatitis C virus in your blood or to stop the study drug and enter follow-up. You will not be eligible for the “PROVIDE” study as you were not in the control arm. SPRI will notify the study doctor and staff of the subjects who are eligible for the “PROVIDE” study.
Arm 3: Subjects in this arm will receive 44 weeks of boceprevir, along with Peglntron 1.5 mcg/kg and ribavirin.
• Lead-in phase: Peglntron +ribavirin for 4 weeks
• After week 4, boceprevir (800 mg by mouth 3 times a day), will be added to the Peglntron + ribavirin.
• You will continue with boceprevir, Peglntron and ribavirin for up to 44 weeks (for a total duration of 48 weeks).
• At TW 24 the amount of virus in your blood will be measured to determine whether or not you will be continuing the study:
-If the levels of hepatitis C virus are not detectable (no hepatitis C virus measured in your blood), you will continue your assigned study therapy.
-If the hepatitis C virus is detected in your blood after 24 weeks, you will be discontinued from the active study at TW 28. For that reason you might be asked to come to clinic for an unscheduled visit for a test of the amount of hepatitis C in your blood or to stop the study drug and enter follow-up. You will not be eligible for the “PROVIDE” study as you were not in the control arm. SPRI will notify the study doctor and staff of the subjects who are eligible for the “PROVIDE” study.
Unblinding of the study
During the study neither you nor your study doctor or study staff will know whether you are receiving boceprevir, or placebo. After the study is completed at all centers worldwide, and the study report is issued, SPRI will provide the unblinded information to your study doctor. In case of emergency for which it is necessary to know whether you received boceprevir or placebo, your study doctor will call the IVRS (lab) which can provide this information 7days a week 24 hours per day.
BTW...i am calling the big guns on monday and find out once and for all what this study is all about....they didi call me back last week and they gave me an ext number...no offece to my dotors and stuff...but it seems like im in the dark still on details...I WILL FIND OUT
i just re read my papeers from my doc...it says if i am in arm 1 and i dont clear by wk 12....i have 2 options...i can decide to stop,which seems stupid too me...or i can continue with "open label' BOC will be given...it does not mention how long after the 12 weeks tho...but again...it looks good but it dont...its like a trade off...any way i look at these arms...its always better to RVR...seems like thats the most determing factor here...if you get chosen to be in arm 3 you have the best chance to SVR.....BUT...more drug toll on the body....it seems to me its all a trade off....i guess we cant have the cake and it it too again
sorry....im getting the two trail times (navie and nonresponder) mixed up here....but i think you know what im talkn about....
...if you are clear at week 28
i meant to say if yu stop tx at week 28 and clear by wek 8
YOU SAID:
In our Arm 2, if und at TW8, you are DONE. Kinda scary.
it is,but at the same time its not...if you are clear at week 28...your odds are 82% to SVR.thats based on the lastest naive trial results...BUT...if are still detectable at week 28,you do another 12 weeks...now im not sure if those extra 12 weeks will be SOC,or with BOC/PLECBO..you know about that/?
....me thinks i want to clear at wk 28
AS FOR THE the arm 1 ,i think if your not clear by week 12...you get the real stuff